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

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RecordFirmDate
RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) (K884250)Mentor Corp.1989-06-12
TEGASORB(TM) ULCER DRESSING, #90-XXX (K891288)3M Company1989-06-09
MICRO-STRAIGHT POSTURE TRAINING DEVICE (K884976)Mcdowell Ent., Inc.1989-06-09
WATER JEL STERILE GEL-SOAKED BURN DRESSING (K892360)Pfizer, Inc.1989-06-05
VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ) (K891008)Micromedical Technologies, Inc.1989-05-31
VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS (K891133)Elwyn, Inc.1989-05-24
WEDGE PRESSURE DRESSING (K891189)Durden Enterprises, Inc.1989-05-24
LACRIMAL EFFICIENCY TEST (TM) (K890714)Lacrimedics, Inc.1989-05-17
TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT (K890919)Eagle Vision, Inc.1989-05-16
DRI-VENT ARTERIAL BLOOD SAMPLING KIT (K883840)Concord Laboratories, Inc.1989-05-16
ACTIDERM*-OPAQUE (K892232)Convatec, A Division of E.R. Squibb & Sons1989-05-05
COATED APEX PROBE (K890735)Analytic Technology1989-04-19
NON-ABSORB GAUZE SURG SPONGE & WOUND DRESS/EXT USE (K891460)Smith & Nephew United, Inc.1989-04-17
COMFORTRON DENTAL ANESTHESIA APPARATUS (K884586)M. D. Products1989-04-14
EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE (K890920)Eagle Vision, Inc.1989-04-11
PRE-MOISTENED CLEANSING PAD (K890514)Bausch & Lomb, Inc.1989-04-10
BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET (K891406)Cook Urological, Inc.1989-04-07
NU-DERM HYDROCOLLOID DRESSING (K890545)Johnson & Johnson Patient Care, Inc.1989-03-23
WATER JEL STERILE GEL-SOAKED BURN DRESSING (K885321)Pfizer Pharmaceuticals1989-03-22
ABUSCREEN FP FOR PHENCYCLIDINE (K890882)Roche Diagnostic Systems, Inc.1989-03-15
STERILE LAPAROTOMY SPONGES (K890770)Cypress Medical Products, Ltd.1989-03-14
NON-STERILE, BULK GAUZE SPONGES (K890727)Cypress Medical Products, Ltd.1989-03-10
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH (K885045)Baxter Healthcare Corp1989-03-03
BALANCE SYSTEM (K884926)Chattanooga Group, Inc.1989-02-27
POLYGLUCOSE POWDER (K884422)Anthony N Silvetti, M.D., S.C.1989-02-22
ABSORBENT GAUZE ROLL (K885143)Smith & Nephew, Inc.1989-02-10
ACA DU PONT METHOTREXATE (MTHO) METHOD (K884744)E.I. Dupont DE Nemours & Co., Inc.1989-01-30
GAUZE SWABS, NON-STERILE (K885142)Smith & Nephew, Inc.1989-01-24
KOENIG TOTAL TOE IMPLANT (K884561)Dow Corning Wright1989-01-24
UNNA BOOT DRESSING W/CALAMINE (K883224)Graham-Field, Inc.1989-01-05
PHARMASEAL STERILE WOUND CARE DRESSING (K884397)Baxter Healthcare Corp1988-12-27
HEMORX COLD PACK (K883984)Bio-Dyne, Inc.1988-12-22
GAUZE SPONGE (K884826)Medical Action Industries, Inc.1988-12-22
CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR (K884413)Valleylab, Inc.1988-12-02
CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. (K884412)Valleylab, Inc.1988-12-02
ETA (K883853)Sevrain-Tech, Inc.1988-11-17
DEXSOL (K883854)Northern Scientific, Inc.1988-11-16
SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS (K883091)Sharplan Lasers, Inc.1988-10-14
VIADERM (K882590)Applied Biomedical Sciences1988-10-07
SKINCOTE (K882567)Dynarex Corp.1988-10-05
AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT (K883522)Amerimed US Corp.1988-09-30
COMPEED ATHLETIC DRESSING (K883588)Coloplast A/S1988-09-22
PRO-FECT LAPAROTOMY SPONGES (K882021)Network Trading Corp.1988-08-26
EV MONOCANALICULAR STENT (TM) (K883233)Eagle Vision, Inc.1988-08-22
STICK SPONGE (K882712)Bioseal1988-08-03
GAUZE SPONGE 12PLY (K882711)Bioseal1988-08-03
INTESTINAL SPONGES (K882710)Bioseal1988-08-03
SORBSAN TOPICAL WOUND DRESSING (K881854)E.G. Dick & Assoc.1988-07-19
BUTCHER STRUNG TONSIL SPONGE (K882529)Ormed Mfg., Inc.1988-07-18
GAUZE SPONGE (K882527)Ormed Mfg., Inc.1988-07-18
CYLINDRICAL SPONGE (K882528)Ormed Mfg., Inc.1988-07-18
TAPE STRUNG TONSIL SPONGE (K882530)Ormed Mfg., Inc.1988-07-18
EMIT HVA PHENCYCLIDINE ASSAY (K882179)Syva Co.1988-07-12
FERTILITY FORECASTER COMPUTER PROGRAM (K880618)Fertile Time, Ltd.1988-06-24
HYDROCOLLOID DRESSING FOR PSORIASIS (K881039)Hollister, Inc.1988-06-22
ACE ICPM SIDE PORTED NEEDLE (K881858)Buckman Co., Inc.1988-05-27
ADVANCE DIAGNOSTICS DISPOSABLE EYECUP (K881369)Advantage Diagnostics Corp.1988-05-13
BARD (R) ESKA ERECTIOMETER (K880903)C.R. Bard, Inc.1988-05-06
ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY (K874591)Vitreo Dynamics, Co.1988-05-03
GAUZE AND LAP SPONGES -STERILE & NON-STERILE (K881395)A Plus International, Inc.1988-04-28
DUODERM(R) HYDROACTIVE(R) PASTE (K881302)Convatec, A Division of E.R. Squibb & Sons1988-04-28
PRECISION SPINAL ADJUSTER MODEL 115 (K870910)Kinetic Technology, Inc.1988-04-26
GLANDOSANE (SALIVART) SYNTHETIC SALIVA (K874106)Fresenius USA, Inc.1988-04-15
SURGITEK NPT MONITOR (K875333)Surgitek1988-04-13
DX101-T ULTRASONIC SURGICAL SYSTEM (K880815)Niic U.S.A., 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
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
LAPAROTOMY SPONGES (K874065)Interpro Intl., Inc.1987-11-04
LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE (K873756)Diagnostic Products Corp.1987-10-15
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