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3,119 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
DX101-T ULTRASONIC SURGICAL SYSTEM (K880815)Niic U.S.A., Inc.1988-04-13
NANOLAS ND:YAG OPHTHALMIC LASER (K881459)Biophysic Medical, Inc.1988-04-13
DX101 ULTRASONIC SURGICAL SYSTEM (K880814)Niic U.S.A., Inc.1988-04-13
E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY (K873604)Electronic Waveform Laboratory, Inc.1988-04-12
INVESTIGATION KIT, SEXUAL ASSAULT DETERMINATION (K880208)Dresser Argus, Inc.1988-04-12
TEGASORB ULCER DRESSING #90-XXX (K872298)3M Company1988-04-01
NON ADHERENT PAD (K880788)Cederroth, Inc. USA1988-04-01
JOHNSON & JOHNSON FLUFF SPONGE (K881222)Johnson & Johnson Professionals, Inc.1988-03-28
FERRIS HYDROPHILIC DRESSING (K880330)Ferris Mfg. Corp.1988-03-23
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA. (K881048)Smith & Nephew, Inc.1988-03-21
CHERRY SPONGE (K880853)Ormed Mfg., Inc.1988-03-17
FLAT STICK SPONGE (K880851)Ormed Mfg., Inc.1988-03-17
TRIANGLE SPONGE (K880907)Ormed Mfg., Inc.1988-03-17
ROSEBUD DISSECTORS (K880852)Ormed Mfg., Inc.1988-03-17
ROUND STICK SPONGES (K880910)Ormed Mfg., Inc.1988-03-17
TRACHEOTOMY SPONGES (K880909)Ormed Mfg., Inc.1988-03-17
BLUNT SPONGE (K880911)Ormed Mfg., Inc.1988-03-17
STRUNG ABSORBENT BALLS (K880854)Ormed Mfg., Inc.1988-03-17
MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. (K880172)Cooper Lasersonics, Inc.1988-03-11
REPLICARE (K880299)United Medical1988-02-26
DERMATOLOGICAL PATCH (K872926)Convatec, A Division of E.R. Squibb & Sons1988-02-22
BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 (K880166)Clinical Technology Corp.1988-02-18
REVISED LABELING FOR ADX PHENCYCLIDINE (K880011)Abbott Laboratories1988-02-11
FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS (K874607)Organon Teknika Corp.1988-01-27
ENVINET(TM) (K874551)Marion Laboratories, Inc.1988-01-22
WATER-JEL(R) BURN DRESSING (K864841)Trilling Resources, Ltd.1988-01-22
ACE INTRA COMPARTMENTAL PRESSURE MONITOR (K873684)Ace Medical Co.1988-01-20
PHARMANET (TM) (K872572)Pharmacia, Inc.1988-01-14
REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS (K874626)Syva Co.1988-01-11
COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE (K873605)Pain Prevention Laboratory, Inc.1987-12-30
GUAZE SPONGES (K874067)Interpro Intl., Inc.1987-12-14
REVISED LABELING FOR TDX PHENCYCLIDINE (K874484)Abbott Laboratories1987-11-23
S3 MEDICATED GAUZE (K874219)Surgical Specialties, Inc.1987-11-23
COMFEEL ULCUS ULCER CARE SYSTEM (K873669)Coloplast A/S1987-11-17
REVISED LABELING FOR PCP TEST KIT (K874267)Roche Diagnostic Systems, Inc.1987-11-13
D.R.P. THREE STEP WOUND DRESSING (K871327)Bioderm, Inc.1987-11-09
BONE MARROW COLLECTION KIT AND STAND (K871198)Baxter Healthcare Corp1987-11-06
LAPAROTOMY SPONGES (K874065)Interpro Intl., Inc.1987-11-04
LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE (K873756)Diagnostic Products Corp.1987-10-15
PLAIN DRY GAUZE (K873523)Absorbent Cotton Co., Inc.1987-10-09
EAR AND EYE SPONGES (K873831)Ormed Mfg., Inc.1987-10-05
RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING (K872093)Ics Medical Corp.1987-09-16
AQUATULLE FINE MESH NON-ADHERING DRESSING (K872759)Smith & Nephew, Inc.1987-09-04
FERRIS TRANSPARENT WOUND DRESSING W/HYDROCOLLOID (K871675)Ferris Mfg. Corp.1987-08-06
STICK SPONGE, STRUNG TONSIL SPONGE DOUBLE STRUNG (K872806)American Silk Sutures, Inc.1987-08-04
CHEVRON TAPE DISSECTOR, 9/16 X 1/4, 9/16 X 1/8 (K872808)American Silk Sutures, Inc.1987-08-04
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING (K872624)Smith & Nephew, Inc.1987-07-29
CUTINOVA(R) PLUS FOAM GELFILM (K864913)Beiersdorf, Inc.1987-07-24
GENDER CHOICE INFORMATION KIT, FEMALE AND MALE (K870999)Procare C/O Wiley, Rein & Fielding1987-07-14
ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER (K870773)Hgm, Inc.1987-07-10
AMERICAN PHARMASEAL WOUND DRESSING (K871770)American Pharmaseal Div. Ahsc1987-06-26
ELASTO-GEL OCCLUSIVE DRESSING (K872165)Southwest Technologies, Inc.1987-06-26
NOCTURNAL PENILE TUMESCENCE MONITOR (K870983)Texas Medical Electronics Co.1987-06-23
CUSA SYSTEM 200 MACRO-DISSECTOR (K864983)Cooper Lasersonics, Inc.1987-06-23
HEMOREST(TM) (K864470)Health Aid Products1987-06-23
CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE (K864610)Inframed, Inc.1987-06-18
FRASTEC DRY GAUZE BANDAGE (K871917)Fraass Survival Systems, Inc.1987-06-16
FRASTEC DRY BURN DRESSING (K871916)Fraass Survival Systems, Inc.1987-06-16
ENDOCATER (K863393)The Hygenic Corp.1987-06-11
OMEGA NASAL SEPTAL BUTTON (K871072)Omega Silicone, Inc.1987-06-08
FIRST AID KIT, VARIOUS SIZES (K871376)Fraass Survival Systems, Inc.1987-06-04
KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE (K871501)Fraass Survival Systems, Inc.1987-06-02
TRACHEOSTOMY & NASAL SUCTIONING KIT, 3C-TNS-1 (K871692)Automatic Liquid Packaging, Inc.1987-06-01
MODIFIED HERCON ANTISEPTIC TRANSPARENT DRESSING (K871255)Hercon Laboratories Corp.1987-05-29
FIRST AID KIT, EYE DRESSING (K871457)Fraass Survival Systems, Inc.1987-05-29
CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER (K865056)Cox-Uphuff Intl.1987-05-22
AMERICAN ALCOHOL PREP PAD STERILE MEDIUM (K870718)Span-America Medical Systems, Inc.1987-05-07
OVU-TRAC OVULATION TIMING KIT (K870528)Ob/Gyn Concepts, Ltd.1987-05-06
BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52 (K871438)Fraass Survival Systems, Inc.1987-05-06
CUI NASAL SEPTUM BUTTON (K871200)Cox-Uphuff Intl.1987-04-15
PAD, PETROLATUM & BISMUTH TRIBROMOPHENATE IMPREG. (K870430)Steridyne Laboratories, Inc.1987-04-13
DOC'S PROPLUGS EAR PLUGS (K862045)Doc'S Proplugs, Inc.1987-04-10
MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM (K870249)Bioclinical Laboratory Services, Inc.1987-04-06
MODIFIED MCCAREY-KAUFMAN CORNEAL STORAGE MEDIUM (K870250)Bioclinical Laboratory Services, Inc.1987-04-06
CHONDROITIN SULFATE CORNEAL STORAGE MEDIUM (K870251)Bioclinical Laboratory Services, Inc.1987-04-06
HERCON ANTI. TRANS. DRESSING AS A WOUND DRESSING (K870743)Hercon Laboratories Corp.1987-04-06
1X5YD,2X6YD,3X5YD,4X6YD,1/2/3X10YD GAUZE (K871002)Advantage Credit Services, Inc.1987-03-31
18X36,36X36,18X72,24X72 GAUZE COMPRESS (K871005)Advantage Credit Services, Inc.1987-03-31
2, 3 AND 4 BANDAGE COMPRESS (K870993)Advantage Credit Services, Inc.1987-03-31
MCGHAN TISSUE EXPANDER FILL SYSTEM (K870754)Mcghan Medical Corp.1987-03-31
ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 (K864500)Analytic Technology1987-03-19
GAUZE, ABSORBENT, IODOFORM IMPREGNATED (K870431)Steridyne Laboratories, Inc.1987-02-26
IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C (K865027)Cis-Us, Inc.1987-02-26
RUBYCELL(TM) SYNTHETIC ISLAND DRESSING (K870352)Bioderm, Inc.1987-02-26
WHITE PLUME ABSORBENT GAUZE (K870308)China National Medicines & Health Prod. I/E Corp.1987-02-24
WHITE PLUME GAUZE SPONGE (K870314)China National Medicines & Health Prod. I/E Corp.1987-02-24
POREX(TM) TISSUE EXPANDER (K870154)Porex Medical1987-02-24
25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY (K864166)Weck Surgical Systems1987-02-10
TAMPER HAMPER (K863872)Hydro-Med Products, Inc.1987-02-10
COMPRESS AND BANDAGE, VARIOUS SIZES (K870241)Fraass Survival Systems, Inc.1987-02-06
BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES (K870184)Fraass Survival Systems, Inc.1987-02-06
FERRIS DYNADERM PLUS (K865089)Ferris Mfg. Corp.1987-02-04
ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES (K865095)Kor-Medical Industries, Ltd.1987-01-20
CHARTER HARD CONTACT LENS CLEANING SOLUTION (K865111)Paco Pharmaceutical Services, Inc.1987-01-20
AIMED GAUZE SPONGE (K865097)Kor-Medical Industries, Ltd.1987-01-20
BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER (K865033)Cox-Uphuff Intl.1987-01-12
MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN (K864184)Mcghan Medical Corp.1986-12-24
MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN (K864185)Mcghan Medical Corp.1986-12-24
ZENEX MEDICAL, INC. GAUZE SPONGES (K864298)Zenex Medical, Inc.1986-12-04
VISCOPASTE ZINC PASTE BANDAGE (K863930)Smith & Nephew, Inc.1986-12-01
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