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3,051 FDA 510(k) clearances · Device class

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RecordFirmDate
MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY (K072956)Derma Sciences, Inc.2007-11-07
BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE (K072681)Lifescience Plus, Inc.2007-11-02
EXCELARREST FOAM (K072900)Hemostasis, LLC2007-10-26
PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES) (K070520)Biolife, LLC2007-10-23
ACTIVATOR V SPINAL ADJUSTING INSTRUMENT (K072519)Activator Methods International, Ltd.2007-10-23
ORAL NEUTRALIZER (K071617)Oral Biotech2007-10-19
QUIKCLOT EX (K072474)Z-Medica Corporation2007-10-16
INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 (K072113)Integra Lifesciences Corp.2007-10-10
THROMBIX PATCH THROMBIN HEMOSTASIS PATCH (K072117)Vascular Solutions, Inc.2007-10-05
MEDICAL MAGGOTS, CREATURE COMFORTS (K072438)Monarch Labs, LLC2007-10-05
NEUTROPHASE WOUND CLEANSER (K071056)Novabay Pharmaceuticals2007-09-28
BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17 (K071578)Lifescience Plus, Inc.2007-09-27
HARMONIC 10CM COMBINATION HOOK BLADE (K072203)Ethicon Endo-Surgery, LLC2007-09-25
APEXNRG-BLUE ELECTRONIC APEX LOCATOR (K071133)Medicnrg , Ltd.2007-09-21
KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 (K070685)Tyco Healthcare2007-09-14
KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 (K070653)Tyco Healthcare2007-09-12
DEN TEK COMFORT FIT NIGHTGUARD (K072147)Den Tek Oral Care, Inc.2007-08-30
WOUNDSTAT, MODEL TC1001 (K071936)Traumacure, Inc.2007-08-23
ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC (K071703)Swiss American Products, Inc.2007-08-22
SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC (K063190)Noble Fiber Technologies, Inc.2007-08-21
INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP (K071669)Integra Radionics, Inc.2007-08-17
SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE (K071404)Power Products, Inc.-Splintek2007-08-17
KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 (K070360)Kirwan Surgical Products, Inc.2007-08-07
THROMBI-PASTE THROMBIN/GELATIN POWDER PASTE HEMOSTAT (K070938)Vascular Solutions, Inc.2007-08-06
HEMCON CHITOFLEX-SURGICAL DRESSING (K071519)Hemcon, Inc.2007-08-06
ALLEVYN AG DRESSING (K063835)Smith & Nephew, Inc.2007-08-03
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 (K071079)Gambro Bct, Inc.2007-08-02
BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 (K070201)C.R. Bard, Inc.2007-08-01
PSI BANDS (K070766)Psi Health Solutions, Inc.2007-07-26
L-MESITRAN HYDRO, L-MESITRAN BORDER, L-MESITRAN NET, L-MESITRAN ACTIVE (K053613)Theo Manufacturing BV2007-07-25
AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC (K070175)Medtrade Products , Ltd.2007-07-25
SILVAKLENZ SKIN AND WOUND CLENSER SOLUTION (K063069)Medical Molecular Therapuetics, LLC2007-07-13
SILCRYST SILVER ANTIMICROBIAL WOUND CREAM, MODEL A-00901 (K063805)Nucryst Pharmaceuticals, Inc.2007-07-13
MEPILEX AG DRESSING (K071354)Monlycke Health Care2007-07-13
SILVER ALGINATE II WOUND DRESSING (K070581)Advanced Medical Solutions Limited2007-07-13
HONEY ALGINATE DRESSING (K053095)Derma Sciences Canada, Inc.2007-07-12
ENDO-CHX (K070401)Essential Dental Systems, Inc.2007-07-11
ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL (K070333)Acrymed, Inc.2007-07-10
SILVACIDE SKIN & WOUND MOISTURIZING SOLUTION (K063063)Medical Molecular Therapuetics, LLC2007-07-03
SILICONE TISSUE EXPANDER (K070303)Specialty Surgical Products2007-06-22
UNITE BIOMATRIX (K071425)Pegasus Biologics, Inc.2007-06-20
ULCELOOCIN ORAL ULCER PATCH (K070842)Sunshine International Group, Inc.2007-06-07
MP 719 (K070557)Marine Polymer Technologies, Inc.2007-05-23
MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K070313)Misonix, Inc.2007-05-11
SORBACT WOUND DRESSING (K063059)Abigo Medical AB2007-04-19
KOREBALANCE (KINESTHETIC ABILITY TRAINER) (K070676)Sportkat, LLC2007-04-18
AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING (K063271)Convatec, A Division of E.R. Squibb & Sons, LLC2007-04-16
3M TEGADERM CHG DRESSING (K063458)3M Company2007-04-05
TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM (K070211)Hemostasis, LLC2007-04-05
SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP (K984204)Argentum International, LLC2007-03-19
SILVERLON ADHESIVE STRIP (K984205)Argentum International, LLC2007-03-19
RETRO-TECH DRESSING (K060832)Retro-Tech, LLC2007-03-13
GENGIGEL MOUTHRINSE (K053342)Ricerfarma Srl2007-03-13
NIGHT GUARD (K061122)Alpine Oral Care, LLC2007-03-12
MODIFICATION TO COLLAWOUND DRESSING (K070269)Collamatrix Co., Inc.2007-03-02
BALANCE REHABILITATION UNIT (BRU) (K070085)Medicaa (Uruguay) S.A.2007-02-26
SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM (K063531)Sra Developments, Ltd.2007-02-22
HEALADEX-P (K063517)Healagenics, Inc.2007-02-16
EXSEPT WC WOUND CLEANSER (K061467)Alcavis International, Inc.2007-02-15
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT (K063860)Vascular Solutions, Inc.2007-02-13
EUSOL-C (K063617)Al.Chi.Mi.A2007-02-08
HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP (K063192)Ethicon Endo-Surgery, LLC2007-01-30
URGOCELL AG ANTIMICROBIAL WOUND DRESSING WITH SILVER (K062559)Laboratoires Urgo2007-01-29
QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER (K070010)Z-Medica Corporation2007-01-25
MEPILEX AG ABSORBENT SILICONE-COATED DRESSING (K061554)Molnlycke Health Care2007-01-25
DEN TEK NIGHTGUARD (K063483)Den Tek Oral Care, Inc.2007-01-23
SOCK IT! ORAL PAIN GEL (K063148)Merlin Group Dba Mcmerlin Dental Company2007-01-17
LOCOBASE WOUND AND SKIN EMULSION (K060272)Ferndale Laboratories, Inc.2007-01-12
STRAUMANN PREFGEL (K063812)Straumann USA2007-01-12
X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER (K063632)C.R. Bard, Inc.2007-01-05
AR1000 ULTRASONIC WOUND THERAPY SYSTEM (K062544)Arobella Medical, LLC2007-01-03
APEXNRG XFR (K063843)Medicnrg , Ltd.2007-01-03
RIGIDOMETER, MODEL DIR-4U (K061676)Uroan 212006-12-27
CITRIC ACID 20% SOLUTION, MODEL 329 (K063703)Ultradent Products, Inc.2006-12-21
HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER (K061227)The Hymed Group Corp.2006-12-20
REST ASSURED NITE PROTECTOR (K063229)Ranir, LLC2006-12-19
MUGARD MUCOADHESIVE ORAL WOUND RINSE (K062795)Access Pharmaceuticals, Inc.2006-12-11
MOUTHGUARD AND ALIGNER MATERIALS (K062828)Dentsply Intl., Inc.2006-11-27
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V (K062094)Ortho-Clinical Diagnostics, Inc.2006-11-22
ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY (K063330)Orthocon, Inc.2006-11-22
SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S (K062212)Anacapa Technologies, Inc.2006-11-21
MODIFICATION TO SILVER ALGINATE II WOUND DRESSING (K063173)Advanced Medical Solutions Limited2006-11-03
OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 (K060987)Cp Medical2006-11-02
MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098 (K062653)Parnell Pharmaceuticals, Inc.2006-10-27
ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF (K062471)Misonix, Inc.2006-10-26
SINCLAIR SEBORRHEA EMULSION (K050158)Sinclair Pharmaceuticals, Ltd.2006-10-11
MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER (K053538)Curapharm, Inc.2006-10-10
MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER (K062421)Mentor Corporation2006-10-10
D-STAT DRY HEMOSTATIC BANDAGE (K061219)Vascular Solutions, Inc.2006-10-06
SILVERLON CA (CALCIUM ALGINATE) (K053590)Argentum Medical, LLC2006-10-06
ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 (K061232)Acrymed, Inc.2006-10-06
COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID (K061746)Innocoll Pharmaceuticals2006-10-02
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH (K062000)Ethicon Endo-Surgery, Inc.2006-09-25
DERMADAPT WOUND DRESSING (K061494)Pegasus Biologics, Inc.2006-09-21
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 (K062391)Triage Medical, Inc.2006-09-14
ALGICELL AG (K052536)Derma Sciences Canada, Inc.2006-09-13
PLETHORA SOLUTIONS SEXUAL ASSESSMENT MONITOR (SAM) (K062042)Plethora Solutions2006-09-06
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE) (K060734)Fresenius Medical Care North America2006-09-05
AQUATINE EC ENDODONTIC CLEANSER (K061689)Puricore, Inc.2006-08-24
ACUBAND ACUPRESSURE WRIST BAND DEVICE (K053509)Acuband, Inc.2006-08-16
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