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

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RecordFirmDate
EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR (K934592)Abaxis, Inc.1994-04-06
SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD) (K935723)Cabot Safety Corp.1994-04-06
E.M.A. (K940614)European Manufacturers Agency, Inc.1994-04-06
SPECTACLE FRAMES AND SUNGLASSES (K935974)Pan Oceanic Eyewear1994-04-06
SPECTACLE FRAMES (K935845)New Star Corp.1994-04-06
POWDER FREE GLOVES (K935088)Avt Rubber Products , Ltd.1994-04-05
R AND D BATTERY REPLACEMENT (K933337)R & D Batteries, Inc.1994-04-05
DOCUMENT(R) ZERO (K940568)Casco Standards1994-04-05
JOBSKIN CONTINUING CARE (K925583)Jobst Institute, Inc.1994-04-04
BEHIND THE EAR HEARING AID (K936190)Audina Hearing Instrument1994-04-04
TMC I, II (K930534)Ciba Corning Diagnostics Corp.1994-04-04
PROFILE IC; PROFILE CLEARVOICE; PROFILE (K940100)Beltone Electronics Corp.1994-04-01
MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS (K932240)Bailey Mfg. Co.1994-04-01
BELTONE OPERA/OPERA MHP/OPERA MAX (K940102)Beltone Electronics Corp.1994-04-01
OSHER SURGICAL GONIO/POSTERIOR POLE LENS (K935302)Ocular Instruments, Inc.1994-04-01
MID LABS TWIN ILLUMINATOR (K932131)Medical Instrument Development Laboratories, Inc.1994-04-01
BELTONE ODE AND BELTONE ODE VX; ODE CLEARVOICE IC AND BELTONE ODE VX CLEARVOICE IC; BELTONE ODE CLEARVOICE ANF AND (K940103)Beltone Electronics Corp.1994-04-01
7500 DATA TOWER (K935498)E-Systems, Inc.1994-04-01
OTOSONIC (OSI) LPS D; LPS D IC; LPS D ASP (K940099)Beltone Electronics Corp.1994-04-01
OTOSONIC ACS II D WITH SRR (K940101)Beltone Electronics Corp.1994-04-01
SUNGLASSES (K935099)Taiwan Tong AI Co., Ltd.1994-04-01
SCMD KERATOME (K935342)S.C.M.D. Keratomes of Arizona1994-04-01
OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP) (K940177)Beltone Electronics Corp.1994-04-01
CUSTOM CV PACK (K936255)Associated Medical1994-03-31
HEP-2 CULTURE CELL (K933927)Neogenex1994-03-31
UNIPOWER RECHARGEABLE BATTERY PACK (K936141)Unipower Corp.1994-03-31
OMNI WARM GEL PACKS (K936084)Omni Therm, Inc.1994-03-31
ULTRACAM (K933671)Dental Vision Direct, Inc.1994-03-31
ENDEX ENDOSCOPIC POSITIONING SYSTEM (K936308)Andronic Devices, Ltd.1994-03-31
SKIN BIOPSY DEVICE (K933324)Nhr, Inc.1994-03-31
KAPTON PEEL POUCH (K933228)American Fluoroseal Corp.1994-03-30
AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER (K925907)Pollenex Corp.1994-03-30
RAREX GREEN FAST (K941023)Mci Optonix, Inc.1994-03-30
CUSTOM ENT PACKS (K935621)Associated Medical1994-03-30
DIADOT(TM) VIRUS/CHLAMYDIA TRANSPORT (K931922)Viratest Intl., Inc.1994-03-30
CEDARS-SINAI QUANTITIVE THALLIUM 201 ANALYSIS (K932701)Nuccardiac Software, Inc.1994-03-29
A549 CULTURE CELL (K933923)Neogenex1994-03-29
KAPPLER PRO/VENT BOOT (K932738)Kappler, Inc.1994-03-29
MCCOY CULTURE CELL (K933924)Neogenex1994-03-29
FUJINON VIDEO LAPAROSCOPE, MODIFIED (K930297)Fujinon, Inc.1994-03-29
MRC-5 CULTURE CELL (K933925)Neogenex1994-03-29
LLCMK2 CULTURE CELLS (K933926)Neogenex1994-03-29
CIDEX PLUS 28 DAY SOLUTION (K923744)Johnson & Johnson Medical, Inc.1994-03-29
CIDEX ACTIVATED DIALDEHYDE SOLUTION (K924434)Johnson & Johnson Medical, Inc.1994-03-29
A013 FEMI-FORM FACIAL MASSAGER (K931637)Fairform Mfg., Co., Ltd.1994-03-28
FO96 HANDY MASSAGER (K931638)Fairform Mfg., Co., Ltd.1994-03-28
MIDMARK MAGNUM GENERAL SURGICAL TABLE (K934744)Midmark Corp.1994-03-28
FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER (K931636)Fairform Mfg., Co., Ltd.1994-03-28
IL TEST(TM) TRIGLYCERIDE (K931116)Instrumentation Laboratory CO1994-03-28
F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR (K931639)Fairform Mfg., Co., Ltd.1994-03-28
MEDSURG STERILE IMAGING PRODUCTS (K934731)Medsurg Industries, Inc.1994-03-28
AO11 BODY MASSAGER (K931640)Fairform Mfg., Co., Ltd.1994-03-28
PATIENT EXAMINATION GLOVES (K931798)Graintrade , Ltd.1994-03-28
NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS (K933600)Navarre Biomedical , Ltd.1994-03-28
UNSCENTED MENSTRUAL PAD TIER-1 REVIEW (K940377)Eldari, Ltd.1994-03-25
LORI-CIC HEARING AID (K940639)Lori Medical Laboratories, Inc.1994-03-25
ORVIS MARQUESAS FISHING GLASSES (K940354)The Orvis Co., Inc.1994-03-24
UNIVERSAL CUSHIONED METAL EYE SHIELD (K940213)P.J. Products, Inc.1994-03-24
SUNGLASSES (NON-PERSCRIPTION) (K934567)Jaan Huey Co., Ltd.1994-03-24
ORVIS RIVER GUIDE GLASSES (K940292)The Orvis Co., Inc.1994-03-24
STRETCHPOWER (K935188)Orthopedic Development, Inc.1994-03-24
ACU-E PUNCH (K933516)Acuderm, Inc.1994-03-24
STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER (K934175)Orthopedic Development, Inc.1994-03-24
JAW SPREADER (K936050)Gam Industries, Inc.1994-03-24
UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD (K940275)P.J. Products, Inc.1994-03-24
OTOSONIC MINI PAS (K940104)Beltone Electronics Corp.1994-03-24
PADS MENSTRUAL, UNTREAT DEODORIZED, VARIOUS SIZES (K933879)Universal Health Care Products Canada, Inc.1994-03-24
ACTION PATRIOT MANUAL WHEELCHAIR (K930803)Invacare Corp.1994-03-24
FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE (K933770)Mahe-Medizintechnik1994-03-23
ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE (K940480)Acufex Microsurgical, Inc.1994-03-23
BIOSHIELD BLUE LATEX GLOVES (K940256)Chester Labs, Inc.1994-03-23
ORTHOTECH DURA-GOLD BARCKETS (K933080)Orthotech1994-03-23
CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES (K935356)Amsco American Sterilizer Co.1994-03-23
FAMILY FIRST AID KIT (K935131)Medical Technologies International, Inc.1994-03-23
STB GUEDEL AIRWAY (K933760)Save-T-Breath Distributors C.C.1994-03-23
POWDER-FREE LATEX EXAMINATION GLOVES (K935812)Shen Wei (Usa), Inc.1994-03-23
BIOSHIELD BLUE POWDER FREE GLOVE (K940254)Chester Labs, Inc.1994-03-23
ARTHREX TOURNIQUET FOR LEG HOLDER (K933994)Arthrex, Inc.1994-03-23
ASPIR-PULSE(TM) SAF-T-VENT (K940575)Sherwood Medical Co.1994-03-22
FERTILITY PLUS 1, 2, 3 (K935219)Ciba Corning Diagnostics Corp.1994-03-22
QUALITY CONTROL MATERIAL (ASSAYED) (K935819)Columbia Diagnostics, Inc.1994-03-22
DRUGS OF ABUSE CONTROLS (K935285)Medical Diagnostic Technologies, Inc.1994-03-22
SERUM AMMONIA CONTROL (K935606)P.T. Meditrol1994-03-22
AIR CONDUCTION HEARING AID, UNITRON IKON K & KD (K935867)Unitron Industries, Inc.1994-03-22
SYNELISA DHEA-SULFATE (K935469)Elias U.S.A., Inc.1994-03-22
KODAK EKTACHEM DT SLIDES (FE) (K934358)Eastman Kodak Company1994-03-21
RUBBERCARE LOPRO PATIENT EXAMINATION GLOVES, POWDERED (K933759)Perusahaan Pelindung Getah (M) Sdn Bhd1994-03-21
HYGOFLEX SALIVA-EJECTOR (K935758)J.H.Orsing AB1994-03-21
RIONET HEARING AID HB-53CI (K936122)Authorized Hearing Systems, Inc.1994-03-21
AIR CONDUCTION HEARING AID: IKON PP (K936106)Unitron Industries, Inc.1994-03-21
SALIVA EJECTOR DISPOSABLE (K935616)Asa Instruments S.R.L.1994-03-21
AUTO LUBE SYSTEM (K940535)The Anspach Effort, Inc.1994-03-21
MIRACLE-EAR CONFIDANTE (K940458)Miracle-Ear, Inc.1994-03-21
TREATMENT TABLE MODIFICATION (K936303)Tri W-G, Inc.1994-03-18
REVOLUTION LOWER LIMB CPM UNIT (K935808)Toronto Medical, Inc.1994-03-18
VISION (MANUAL WHEELCHAIR) (K934234)Fortress Lite-Style Wheelchairs, Inc.1994-03-17
LEGEND (MANUAL WHEELCHAIR) (K934236)Fortress Lite-Style Wheelchairs, Inc.1994-03-17
WIDEX R.C. 2 (REMOTE CONTROL) (K935424)Widex Hearing Aid Co., Inc.1994-03-17
BUR, SURGICAL, GENERAL & PLASTIC SURGERY (K933595)Omega Surgical Instruments, Inc.1994-03-16
NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX (K934483)Mountain Precision Mfg. Ltd. Co.1994-03-16
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