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

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RecordFirmDate
WELLWASH 4 MARK II (K922803)Denley Instruments, Inc.1992-11-05
VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE (K922960)Cameo, Inc.1992-11-05
DENSPRO MEDIUM MINT PROPHY PASTE (K923675)Teledyne Getz1992-11-05
DENSPRO COARSE MINT PROPHY PASTE (K923674)Teledyne Getz1992-11-05
DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET (K923794)Casco Standards1992-11-05
PHONAK PICO-FORTE PP-SC-2 BTE HEARING INSTRUMENT (K924911)Phonak, Inc.1992-11-04
BIOFORCE WIRE (K920905)Gac Intl., Inc.1992-11-04
PHONAK PICO-FORTE PPC-L-P-2 BTE HEARING INSTR (K924913)Phonak, Inc.1992-11-04
ECO/DENTAL GENERAL DENTAL PACK (K922988)Dyna-Pace Systems, Inc.1992-11-04
PHONAK PICO-FORTE PPC-P-2 BTE HEARING INSTRUMENT (K924914)Phonak, Inc.1992-11-04
LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100 (K921493)Welch Allyn, Inc.1992-11-03
PHONAK PICO-FORTE C-2 BTE HEARING INSTRUMENT (K924912)Phonak, Inc.1992-11-03
STETHOSCOPE COVER (K923327)Anup Chakraborty Co.1992-11-03
DFS GENIUS BTE (K924185)Gn Danavox, Inc.1992-11-03
NIZYME TEST KIT (K923566)Remel Co.1992-11-02
I-STAT(TM) LEVELS 1,2,3 CONTROLS (K921477)I-Stat Corp.1992-11-02
ATRAUM WOUND DRESSING--MODIFICATION (K922760)Axiom Medical, Inc.1992-10-30
GERMAN MINI DYNALOCK (K923432)Unitek Corp.1992-10-30
CONVEEN(R) LEG BAG(500 ML) (K924406)Coloplast A/S1992-10-30
DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED (K922479)Intertech Resources, Inc.1992-10-30
VIBROTACTILE TESTER, MODEL NO. VTT-100 (K921560)Topical Testing, Inc.1992-10-30
FRAY BIO-PUNCH (K921822)Fray Products Corp.1992-10-28
LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC (K924694)Olympus Corp.1992-10-28
DEXTRON SURGICAL GLOVES (K921804)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-10-28
EUDERMIC POWDER-FREE SURGICAL GLOVES (K915807)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-10-28
PATIENT EXAMINATION GLOVES (K923592)Hindustan Latex , Ltd.1992-10-28
IL TEST APOLIPOPROTEIN A1 (K923087)Instrumentation Laboratory CO1992-10-26
IL TEST APOLIPOROTEIN B (APO B) (K923080)Instrumentation Laboratory CO1992-10-26
CHOLESTEROL TEST (K923733)Em Diagnostic Systems, Inc.1992-10-26
VERT-X UNIVERSAL VERTICAL BUCKY STAND (K922443)Afp Imaging Corp.1992-10-26
RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE (K913893)Depuy, Inc.1992-10-23
VIROTHERM HUMIDIFIER (K915603)Virotherm Laboratory1992-10-22
ROCHE REAGENT FOR ALT (K924245)Roche Diagnostic Systems, Inc.1992-10-22
FAMILY EAR SCOPE MODEL 29001S (K923304)Ear Care of So. Ca., Inc.1992-10-21
Q FEVER IGM IFA TEST (K922374)Hillcrest Biologicals1992-10-21
Q FEVER IGG IFA TEST (K913906)Hillcrest Biologicals1992-10-21
PORTABLE LIMB LOAD MONITOR (BMLLM-100) (K915326)Bar Med Pty , Ltd.1992-10-20
TIMEOSCOPE AND FLEXISCOPE (K924095)Stethoscopes of America, Inc.1992-10-20
ELTRAX OPTICAL DISK IMAGE ARCHIVING SYSTEM (K923680)Minnetonka Medical1992-10-20
PREMIER C. DIFFICILE TOXIN A CONTROLS (K924136)Meridian Diagnostics, Inc.1992-10-19
OLYMPUS MAGNESIUM REAGENT (K924658)Olympus Corp.1992-10-19
SURGICAL INSTRUMENT KIT, DISPOSABLE (K920989)Ulti-Med Intl., Inc.1992-10-19
MERITEC C. DIFFICILE CONTROLS (K924062)Meridian Diagnostics, Inc.1992-10-19
ADEPT INSTRUMENT POSITIONING ACCESSORY (K922626)Andronic Devices, Ltd.1992-10-19
DISPOSABLE ENDOILLUMINATOR (K923774)O.R. Specialties, Inc.1992-10-19
ADEPT ENDOSCOPIC POSITIONER (K922625)Andronic Devices, Ltd.1992-10-19
SYLVAN DENTAL HEADLIGHT SYSTEM (K923949)Sylvan Medical Fiberoptics1992-10-16
IRRIVAGE (K922785)Autovage1992-10-16
X-RAY CONTROL AND HI-VOLTAGE GENERATOR (K921875)Continental X-Ray Corp.1992-10-15
GUARDALL SHIELD (K915415)Anago, Inc.1992-10-15
X-RAY DRAPES (K923099)Hydro-Med Products, Inc.1992-10-15
BOSTON BRAND HYPOALLERGENIC LATEX GLOVES (K923385)Boston Medical Corp.1992-10-15
NITINOL GENTLE TOUCH COIL SPRING (K923839)Ultimate Wireforms, Inc.1992-10-15
SOFNOLIME CARBON DIOXIDE ABSORBENT (K921803)Molecular Products , Ltd.1992-10-15
RAPID NFT, MODIFICATION (K922768)Biomerieux Vitek, Inc.1992-10-14
SIENET CAMERA SERVER (K923582)Siemens Gammasonics, Inc.1992-10-14
C-TRAK BIOPSY SYSTEM (K922117)Care Wise Medical Products Corp.1992-10-14
COULTER MULTI-Q-PREP (K923530)Coulter Electronics, Inc.1992-10-14
TWO PART INORGANIC PHOSPHORUS TEST (K924470)Em Diagnostic Systems, Inc.1992-10-14
MICROLITE MICROTITER PLATE LUMINOMETER ML3000 (K923456)Dynatech Laboratories, Inc.1992-10-13
MULTIQUAL UNASSAYED PRODUCTS (K923632)Ciba Corning Diagnostics Corp.1992-10-13
DBA FOCAL CHANGE FRAMES (K923415)Focal Change1992-10-13
MULTIQUAL ASSAY PRODUCTS (K923633)Ciba Corning Diagnostics Corp.1992-10-13
QUICK SEEDER (K913293)Mick Radio-Nuclear Instruments, Inc.1992-10-13
ALCON OPERATING MICROSCOPES (K920641)Alcon Laboratories1992-10-09
COMBINE II WETPROOF PAD (K923116)Hermitage Hospital Products, Inc.1992-10-06
DERMCO A-I (K923400)Dermaco, Inc.1992-10-06
SILIMAT PLUS (K923974)Ivoclar North America, Inc.1992-10-06
STERILE SURGEONS GLOVES -- MODIFICATION (K922769)Real Latex Pvt. , Ltd.1992-10-06
PHARYNGEAL SALIVARY BYPASS TUBE (K923355)Boston Medical Products, Inc.1992-10-06
USP TYPE VII GAUZE SPONGES (K923378)E.W.A., Ltd.1992-10-06
ITC HEARING AID CLUB MODEL LM50 (K923292)Club Hearing Instruments A/S1992-10-05
INDOXYL ACETATE DISK (K923700)Remel Co.1992-10-05
NEEDLE TECHNOLOGIES SEED IMPLANT NEEDLE (K921886)Needle Technologies, Inc.1992-10-05
MEDIPHONIX CUSTOM FULL SHELL CUSTOM CANAL (K924450)Mediphonix, Inc.1992-10-05
MRX-700 (K921129)Mrx-Ray Tube Corp.1992-10-05
ORALSAFE (K923469)Oralsafe, Inc.1992-10-05
DDV LIGATOR (K921304)North American Medical, Inc.1992-10-05
IMMUCHEM PRL-MW ELISA (K922715)Icn Biomedicals, Inc.1992-10-05
ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT (K922376)Icn Biomedicals, Inc.1992-10-05
COMPUTERIZED PUPIL (K920937)Trek Medical Products, Inc.1992-10-02
MICRO TRAK XL SYSTEM (K921747)Syva Co.1992-10-01
LATEX EXAMINATION GLOVES (K922255)Balak Rubber (Malaysia) Sdn. Bhd.1992-10-01
KING DIAGNOSTICS MAGNESIUM REAGENT (K923927)King Diagnostics, Inc.1992-09-30
910T MONTORIZED INSTRUMENT TABLE (K922242)R.H. Burton Co.1992-09-30
PALADISC LC (K923549)Heraeus Kulzer, Inc.1992-09-29
HYSORB WOUND DRESSING (K921502)Kingston Technologies, Inc.1992-09-29
BURNOUT MATERIAL (K923586)Dentsply Intl.1992-09-29
ATAC 6000 CHEMISTRY ANALYZER (K924084)Bio-Chem Laboratory Systems, Inc.1992-09-29
BTE WITH ACCESSORY ATTACHED (K923743)Phonak, Inc.1992-09-28
OLYMPUS IRON REAGENT (K923565)Olympus Corp.1992-09-28
LAP DISK (K923827)Remel Co.1992-09-28
DIASLIDE URINE CULTURING DEVICE (K921045)Savyon Diagnostics , Ltd.1992-09-28
ULTRALITE X-RAY FILM ILLUMINATOR (K922848)A & S Trading Co.1992-09-28
SIL-MED FLAT SUCTION DRAIN (K921424)Sil-Med Corp.1992-09-28
EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000 (K923257)Em Diagnostic Systems, Inc.1992-09-28
RIONET HB75-AL BTE AID (K923801)Authorized Hearing Systems, Inc.1992-09-28
GAMMA GULTAMYL TRANSFERASE TEST (K922947)Em Diagnostic Systems, Inc.1992-09-28
DANPLEX DIAGNOSTIC AUDIOMETER, CLIN. DIAG. AUDIOMT (K923071)Life-Tech Intl., Inc.1992-09-28
SOUNDCHOICE K-AMP (K923735)Bausch & Lomb, Inc.1992-09-28
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