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

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RecordFirmDate
45 DEGREE SHAVER (K870882)Bowen & Company, Inc.1987-03-23
S.C.M.T. PERFORATOR (K871087)Salt Creek Medical Technologies1987-03-23
WINPETTE (K871076)Ulster Scientific, Inc.1987-03-23
LOOSE BODY GRASPERS (K870881)Bowen & Company, Inc.1987-03-23
TIP, DENTAL SUCTION APPARATUS (K870599)Military Engineering, Inc.1987-03-23
HEARTECH HFX, HEARING AID (K870723)Hearing Tech, Inc.1987-03-20
EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR (K870851)Electromed Intl., Ltd.1987-03-20
STERILE PROCEDURAL TRAYS (K870373)Dimed, Intl.1987-03-20
LOOK RETROBULBAR NEEDLES (K870902)Look, Inc.1987-03-20
IODOSORB POWDER (K870559)Perstorp AB C/O Robert Joel Slomoff1987-03-20
NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST (K870117)Pro-Lab, Inc.1987-03-20
CENTRIPREP CONCENTRATOR (K870690)Amicon, Inc.1987-03-19
ALANINE TRANSAMINASE (ALT) TEST KIT (K870879)Genetic Systems Corp.1987-03-19
COAT-A-COUNT PCP KIT NUMBER TKPC1 (K870875)Diagnostic Products Corp.1987-03-19
EASY-TEST URIC ACID (URIC) #16606 (K870868)Em Diagnostic Systems, Inc.1987-03-19
SEWON DENTAL FLOSSER (K870996)Sewon Industry1987-03-19
SOFT EAR STETHOSCOPE (K870600)Kalajian Ent.1987-03-19
MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 (K870809)Adept-Med Intl., Inc.1987-03-19
T-TUBE INSERTER (K870978)Sur-Med Instruments, Inc.1987-03-19
A.T.S. 1500 TOURNIQUET (K870784)Aspen Laboratories, Inc.1987-03-18
THE EXPERIMENTAL (K864455)Martin H. Kaufmann1987-03-18
NOTCH-NEEDLE, WESCOTT STYLE (K870896)Ocean Medical Products, Ltd.1987-03-18
PAD, BED LINEN PROTECTIVE (K870925)Quality Disposables, Inc.1987-03-17
AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE (K870720)American Pharmaseal Div. Ahsc1987-03-17
DIAMOND MEDICAL, INC., MODEL DM 700 (K863298)Diamond Medical, Inc.1987-03-17
THE (CROM) TESTER (K870767)Twin City Surgical, Inc.1987-03-17
WARM WEIGH MODEL N-10 INFANT SCALE (K870888)Air-Shields, Inc.1987-03-17
STAVIP 3000 (K864436)Roseburg SA1987-03-16
MOBILIMB HAND EXERCISER (K870402)Biodynamic Technologies, Inc.1987-03-16
HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER (K870027)Salter Labs1987-03-16
BODYSCAN (K870818)Siemens Gammasonics, Inc.1987-03-16
CHALLENGER DOSIMETER (K870755)Salter Labs1987-03-16
SCHULTZ MP COMPONENT PUNCH (K870846)Warsaw Orthopedic, Inc.1987-03-13
SYVA ETS SYSTEM (K863245)Syva Co.1987-03-13
PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER (K870777)Kone Instruments, Inc.1987-03-13
SHBG IRMA KIT (K861679)Farmos Group , Ltd.1987-03-13
SUNGLASSES (K864543)Image of Hawaii1987-03-13
PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG (K870166)George C. Kuhn1987-03-13
DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID (K870691)Dahlberg Electronics, Inc.1987-03-13
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT (K870828)Intersect Systems, Inc.1987-03-13
FAST URIC ACID (K870632)Sclavo, Inc.1987-03-13
DEPEND UNDERPAD (K870522)Kimberly-Clark Corp.1987-03-13
INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT (K870827)Intersect Systems, Inc.1987-03-13
SCHULTZ PHALANGEAL COMPONENT DRIVER (K870847)Warsaw Orthopedic, Inc.1987-03-13
SCHULTZ METACARPAL COMPONENT DRIVER (K870848)Warsaw Orthopedic, Inc.1987-03-13
SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR (K870844)Warsaw Orthopedic, Inc.1987-03-13
RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT (K870776)Reagents Applications, Inc.1987-03-13
EZ COMPLEMENT REAGENTS, 78N2212 (K870351)Diamedix Corp.1987-03-13
BECKMAN EPSILON(TM) LIPASE TEST KIT (K864438)Beckman Instruments, Inc.1987-03-12
APO B., IMMUNOTURBIDIMETRIC ASSAY (K864228)Intl. Diagnostic Laboratories, Ltd.1987-03-12
TOTAL/IGE THEOPHYLLINE CONTROL SERA (K870151)3M Company1987-03-12
OXY-THERM (K870832)M.D. Intl., Inc.1987-03-12
RICKETTSIAL IGG AND IGM IFA KIT (K864110)Hillcrest Biologicals1987-03-12
AFFINITY(TM) SYSTEM (K865105)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-12
MODIFIED IMAGEN(TM) CHLAMYDIA TEST (K864539)Boots-Celltech Diagnostics, Inc.1987-03-12
HEARING AID, UNITRON MODEL UM60 (K870503)Unitron Industries, Inc.1987-03-11
TORQUEDRIVER WRENCH (K870053)Jerome Medical1987-03-11
WARSAW ORTHOPEDIC POINTED REAMER (K870845)Warsaw Orthopedic, Inc.1987-03-11
MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID (K870435)Telex Communications, Inc.1987-03-11
MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS (K870434)Telex Communications, Inc.1987-03-11
ESCORT EC CUSTOM IN-THE-EAR HEARING AID (K870350)Hearing Tech, Inc.1987-03-11
TANDEM(R)-M FSH IMMUNOENZYMETRIC ASSAY (K870520)Hybritech, Inc.1987-03-10
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST (K870155)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-10
TERUMO DENTAL NEEDLES (K864970)Terumo Medical Corp.1987-03-10
ACROMED WALLIE-HEINIG CURETTES (K870778)Buckman Co., Inc.1987-03-09
DRIVER-BENDER-EXTRACTOR, BONE PIN (K870668)Military Engineering, Inc.1987-03-09
VARIOUS TYES OF SURGICAL GARMENTS (K870617)Greene International Corp.1987-03-09
ACROMED WALLIE-HEINIG TROCHAR (K870779)Buckman Co., Inc.1987-03-09
VARIOUS TYPES OF SURGICAL GARMENTS (K870618)Kin Yuh Hung Co., Ltd.1987-03-09
ACROMED WALLIE-HEINIG DISECTOR/ELEVATORS (K870781)Buckman Co., Inc.1987-03-09
ACROMED WALLIE-HEINIG OSTEOTOMES (K870780)Buckman Co., Inc.1987-03-09
HAWKINS BREAST LOCALIZATION NEEDLE (K870523)N-S Medical Products1987-03-09
SUPER URINE ANALYZER SYSTEM (K870526)Kyoto Daiichi Kagaku Co., Ltd.1987-03-06
ALANINE AMINOTRANSFERASE (ALT)/(GPT) (K870086)Catachem, Inc.1987-03-06
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX (K870553)Em Diagnostic Systems, Inc.1987-03-06
EAR APPLICATOR, CATALOG NO. 2229 (K870762)Treace Medical, Inc.1987-03-06
RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY (K870417)North Coast Medi-Tek1987-03-05
'EXMOOR' ATKINS NASAL SPLINT (K864930)Exmoor Plastics , Ltd.1987-03-04
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608 (K870408)Em Diagnostic Systems, Inc.1987-03-04
TEFLON UTERINE SOUND (K870550)Cook Ob/Gyn1987-03-04
'EXMOOR' SHAH & MACKAY NASAL SPLINTS (K864933)Exmoor Plastics , Ltd.1987-03-04
'EXMOOR' CAWOOD NASAL SPLINTS (K864932)Exmoor Plastics , Ltd.1987-03-04
SMALL MASTOID RETRACTOR (K870758)Treace Medical, Inc.1987-03-04
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607 (K870407)Em Diagnostic Systems, Inc.1987-03-04
MICRO-EAR FULL-CONCHA IN-THE-EAR HEARING AID (K870080)Micro-Ear Hearing Center, Inc.1987-03-03
MICRO-EAR LOW-PROFILE IN-THE-EAR HEARING AID (K870081)Micro-Ear Hearing Center, Inc.1987-03-03
MICRO-EAR CANAL IN-THE-EAR HEARING AID (K870079)Micro-Ear Hearing Center, Inc.1987-03-03
EAR LOOP (K870761)Treace Medical, Inc.1987-03-03
VEIN GRAFT EAR SCISSORS (K870756)Treace Medical, Inc.1987-03-03
THERMAPAD (K864158)Avail-Southwest Division1987-03-02
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS (K870331)Interpore Intl.1987-03-02
SOLUSET CALCIUM DEMINERALIZING SOLUTION (K864976)Endo Technic Corp.1987-02-27
REDMAN ACCESSORIES (K870298)Redman, Inc.1987-02-26
KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L (K870565)Eastman Kodak Company1987-02-26
KODAK X-OMATIC IDENTIFICATION CAMERA DIGITAL (K870701)Eastman Kodak Company1987-02-26
DANNIFLEX 400I (K870510)Buckman Co., Inc.1987-02-26
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL (K864752)Abbott Laboratories1987-02-26
QUICKIE RX PRESCRIPTION WHEELCHAIR (K870476)Motion Designs, Inc.1987-02-26
CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS (K870502)Clinical Convenience Products, Inc.1987-02-26
FUJI CR IMAGING PLATE (K862414)Parexel Intl. Corp.1987-02-26
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