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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
CIDE-SWIPES P-100B & CIDE-SWIPES C-100A (K964376)Mp Scientific, Inc.1996-12-23
REP 3 FLUR SPE-60 KIT (K964453)Helena Laboratories1996-12-23
CORNEAL TOPOGRAPHER 200 (K963762)Eclipse Ventures1996-12-23
DAHLBERG K-AMP BTE (K964794)Miracle-Ear, Inc.1996-12-23
REP FLUR CHOLESTEROL-60 KIT (K964471)Helena Laboratories1996-12-23
VERGE VIDEOMETER (K962148)Verg, Inc.1996-12-20
NITRILE COPOLYMER PATIENT EXAMINATION GLOVES (K962518)P.T. Irama Dinamika Latex1996-12-19
CHLOROPRENE EXAM GLOVES (K963771)P.T. Irama Dinamika Latex1996-12-19
SAFESKIN (K962139)Safeskin Corp.1996-12-19
PELVIC HOLDER (K963465)Deroyal Industries, Inc.1996-12-19
VIREX II 128 GERMICIDAL CLEANER AND DEODORANT (K964828)S.C. Johnson & Son, Inc.1996-12-19
LINX NETWORKING SYSTEM (K964250)Sterling Diagnostic Imaging, Inc.1996-12-18
LASERSHARE PRINT SPOOLER AND/OR SOFTWARE (K963861)Dejarnette Research Systems1996-12-18
PLASTIC SUNGLASSES (K964316)Medical Reports Exchange, Inc.1996-12-17
EYE FIXATION SPECULUM (K964289)Eyefix, Inc.1996-12-17
ELECSYS FSH ASSAY (K964693)Boehringer Mannheim Corp.1996-12-16
COVERAGE SPRAY HBV (K964835)Convatec, A Division of E.R. Squibb & Sons1996-12-16
REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. (K963747)Whitehill Manufacturing, Inc.1996-12-16
STREPTOLEX-STAT (K962296)Unipath , Ltd.1996-12-16
SIGMA DIAGNOSTICS WASH CONCENTRATE (K963539)Sigma Diagnostics, Inc.1996-12-16
ELECSYS CALCHECK LH (K964830)Boehringer Mannheim Corp.1996-12-16
VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT (K964535)S.C. Johnson & Son, Inc.1996-12-13
VIREX II 256 GERMICIDAL CLEANER AND DEODORANT (K964613)S.C. Johnson & Son, Inc.1996-12-13
CANTROL IRON/TIBC CONTROLS, LEVEL 1 AND LEVEL 2 PRODUCT NUMBERS: LEVEL 1: IIBC-91 AND LEVEL 2: IIBC-92 (K964640)Canyon Diagnostics, Inc.1996-12-13
COVERAGE HBV (K964749)Convatec, A Division of E.R. Squibb & Sons1996-12-13
NICCHECK I (K963733)Dynagen, Inc.1996-12-13
TRIAD II DISINFECTANT CLEANER AND DEODORANT (K964610)S.C. Johnson & Son, Inc.1996-12-13
DIGIFOCUS ITE (K964683)Oticon, Inc.1996-12-12
SUNGLASSES OR MULTIPLE (K964429)Trade Resources , Ltd.1996-12-12
CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (K963839)Cordis Corp.1996-12-12
OLYMPUS MOBILE CHAIR/COUCH (K962528)Keymed (Medical & Industrial Equipment), Ltd.1996-12-12
RECOVER ADULT VEIN WARMER (K963689)Florida Medical Industries, Inc.1996-12-12
IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID (K963746)Whitehill Oral Technologies, Inc.1996-12-12
PORPHOBILINOGEN (PBG) (K961984)Trace America, Inc.1996-12-10
DMS-1000C DERMOABRADER (K965256)Mattioli Engineering, Srl1996-12-09
DMS-1000C DERMOABRADER (K963204)Aesthetic Lasers, Inc.1996-12-09
ML MICROKERATOME BLADE (K962661)Med-Logics, Inc.1996-12-09
COUPLING DEVICE FOR DENTAL PROSTHESIS (K950259)Dr. Joseph E. Grasso, D.D.S.1996-12-06
MANAN PROSTATE UNI-LOCK (K963743)Manan Medical Products, Inc.1996-12-06
AHS OMEGA HF (K963878)Authorized Hearing Systems, Inc.1996-12-06
AHS OMEGA CONCEPT (K963877)Authorized Hearing Systems, Inc.1996-12-06
ARTICULAR HEARING AIDS (K964603)Decibel Instruments, Inc.1996-12-06
BIOCIRCUITS IOS QUANTITATIVE HCG TEST CARTRIDGES/BIOCIRCUITS IOS IMMUNOASSAY CONTROLS (K963770)Biocircuits Corp.1996-12-05
TENET TIBIAL FRACTURE SUPPORT (K964102)Tenet Medical Engineering1996-12-05
NOVAGEL SILICONE GEL SHEETING (K963128)Brennen Medical, Inc.1996-12-05
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT (K963958)Beltone Electronics Corp.1996-12-05
PHONAK MICROLINK, PERSONAL FM RECEIVER (K964035)Phonak, Inc.1996-12-04
SPECTRA SCIENCE BIOPSY FORCEPS (K963517)Spectrascience, Inc.1996-12-02
PATIENT RESTRAINTS (K963906)Safety Intl., Inc.1996-12-02
THE WRAP IMMOBILIZATION SYSTEM (K963547)Safe Restraints, Inc.1996-12-02
OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST (K963693)Princeton BioMeditech Corp.1996-11-29
WATERS 515 HPLC PUMP (515) (K964588)Waters Corporation1996-11-29
UNITRON MODEL ICON AOHP +4 (ICON AOHP +4) (K964508)Unitron Industries, Inc.1996-11-27
RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (K964557)Resound Corp.1996-11-27
GLOVEL GX (K963020)Kenwell International , Ltd.1996-11-27
AHS OMEGA K-AMP (K963875)Authorized Hearing Systems, Inc.1996-11-27
DAHLBERG HEARING AID WITH MULTI-CHANNEL COMPRESSION CIRCUIT (K964530)Miracle-Ear, Inc.1996-11-27
PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC (K964451)Rexton, Inc.1996-11-27
UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) (K964510)Unitron Industries, Inc.1996-11-27
GRAND MEDICAL SUTURE REMOVAL KIT (K963714)Grand Medical Products1996-11-27
PRIMOFOCUS COMPACT (K963788)Oticon Corp.1996-11-27
UNITRON MODEL SOUND F/X +4 (K964503)Unitron Industries, Inc.1996-11-27
INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS (K963598)Innovative Technologies , Ltd.1996-11-27
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) (K964511)Unitron Industries, Inc.1996-11-27
STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS (K964244)Starkey Laboratories, Inc.1996-11-27
TRACHEOSTOMY KIT (K963720)Grand Medical Products1996-11-27
UNITRON MODEL SOUND F/XP +4 (K964502)Unitron Industries, Inc.1996-11-27
DERMAGRAN HYDROPHILIC OINTMENT (K963603)Derma Sciences, Inc.1996-11-27
STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS (K964214)Starkey Laboratories, Inc.1996-11-27
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT (K962217)Gen-Probe, Inc.1996-11-27
UNITRON MODEL ICON AOHPL +4 (K964504)Unitron Industries, Inc.1996-11-27
PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF (K964144)Para Scientific Co.1996-11-27
LACERATION TRAY (K963723)Grand Medical Products1996-11-27
AHS OMEGA DEQ (K963873)Authorized Hearing Systems, Inc.1996-11-26
MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) (K963745)Hearing Innovations, Inc.1996-11-26
AHS DELTA 22 (K963879)Authorized Hearing Systems, Inc.1996-11-26
OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING (K962623)Procyte Corp.1996-11-26
MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE (K963704)Shippert Medical Technologies Corp.1996-11-26
AHS OMEGA PP (K963876)Authorized Hearing Systems, Inc.1996-11-26
AUDIO 'D' SOUND SELECTOR POWER (SSP) (K964180)Hearing Solutions, Inc.1996-11-26
TEST-MATE CHE CHOLINESTERASE TEST SYSTEM (K961656)Eqm Research, Inc.1996-11-26
AHS DELTA 22 T (K963881)Authorized Hearing Systems, Inc.1996-11-26
AHS OMEGA AGC (K963874)Authorized Hearing Systems, Inc.1996-11-26
SUNGLASSES(NON-PRESCRIPTION) (K964413)Ever Prime Enterprises , Ltd.1996-11-25
SPENSER SUNGLASSES AND SPORT SUNGLASSES (K964058)Spencer Products Co.1996-11-25
SUNGLASSES (K964082)Neo Vu, Inc.1996-11-25
INSTANT HOT PACKS (K963768)Kick Ice, Inc.1996-11-25
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL (K964422)Roche Diagnostic Systems, Inc.1996-11-25
WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010) (K963559)Tecnol Medical Products, Inc.1996-11-22
PARAMAX AMMONIA AND AMMONIA BLANK REAGENT (K964565)Dade Intl., Inc.1996-11-22
UNISEAL GLOVES (LOW PROTEIN,POWDER FREE) (K963211)American Healthcare Products, Inc.1996-11-22
PROTECTIVE RESTRAINT (WAIST HOLDER) (K963421)Kenad SG Medical, Inc.1996-11-22
WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6 (K964278)Clinical Controls, Inc.1996-11-22
SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS (K963485)Humane Restraint, Inc.1996-11-22
CDR-CAM (K963778)Schick Technologies, Inc.1996-11-22
PROTECTIVE RESTRAINT (PROTECTIVE MITT) (K963422)Kenad SG Medical, Inc.1996-11-22
RESTRAINT ACCESSORIES (K963436)J. T. Posey Co.1996-11-22
POSEY STRAIGHT JACKETS (K963410)J. T. Posey Co.1996-11-22
PERSONAL LIMB HOLDER (24444-200,300,24444-KIT) (K963564)Tecnol Medical Products, Inc.1996-11-22
QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350) (K963552)Tecnol Medical Products, Inc.1996-11-22
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Every clearance here is in the API, with alerts when new ones post.