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

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RecordFirmDate
WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE (K904999)Opticon Medical, Inc.1993-01-26
REFRACTROL-SP (K926095)Medical Specialties, Inc.1993-01-26
OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT (K925337)Olympus Corp.1993-01-26
MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITS (K925231)Merit Medical Systems, Inc.1993-01-26
TRIGLYCERIDES (K924710)Em Diagnostic Systems, Inc.1993-01-26
BBL NINHYDRIN REAGENT DROPPERS (K926256)Becton Dickinson Microbiology Systems1993-01-26
LARYNGOSCOPE RIGID (K922019)Eastmed Enterprises, Inc.1993-01-26
POLYDOROS C (K924078)Siemens Medical Solutions USA, Inc.1993-01-26
IMMUNOCARD(TM) C. DIFFICILE (K924979)Meridian Diagnostics, Inc.1993-01-26
MAXSOFTWARE (K925547)Diagnostic Products Corp.1993-01-26
OLYMPUS URIC ACID REAGENT (K925113)Olympus Corp.1993-01-26
HEAT MOISTURE CONDENSER (K923910)Concord/Portex1993-01-26
BBL PYR REAGENT DROPPERS (K926254)Becton Dickinson Microbiology Systems1993-01-26
MERIDIAN MEDICAL SYSTEMS ADULT ANES BREATH CIRCUIT (K925232)Merit Medical Systems, Inc.1993-01-22
PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC (K915251)Supermax Sdn Bhd1993-01-22
BREAST SHELLS (K923577)Medela, Inc.1993-01-22
PHONOCARDIOGRAPH (K924054)Echo Ultrasound1993-01-22
SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS (K922145)Atos Medical AB1993-01-21
NUTEX GLOVES (K920745)Ansell Intl.1993-01-21
FLUID COOLED BONE SAW BLADE, 6000 SERIES (K924953)Boehringer Laboratories1993-01-21
PHILIPS PRE-FILTER OPTION (K923141)Philips Medical Systems, Inc.1993-01-21
RAYTEL DIGITAL IMAGING SYSTEMS (K922164)Olicon Imaging Systems, Inc.1993-01-21
HOSPITAL KIT ENT 1125 (K922126)Savoy Medical Supply Co., Inc.1993-01-21
IMAGESSSHARE 910 (K925284)Dejarnette Research Systems1993-01-21
VORTECH'S AUTOROUTER (AUTOMATIC IMAGE ROUTING) (K925097)Vortech Data, Inc.1993-01-15
BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT (K925173)Westmed Intl.1993-01-15
NEW DETECTOR OPTION (K924878)Adac Laboratories1993-01-15
EZ VIEW (K925693)Difco Laboratories, Inc.1993-01-15
DRYSLIDE(TM) INDOLE (K925747)Difco Laboratories, Inc.1993-01-15
FISK HEADREST (K924700)Rhino Mfg.1993-01-15
CYTOQUANT COMBINED TRANSPORT MEDIA (K924053)Proteins Intl., Inc.1993-01-15
NEW DETECTOR FOR TRANSCAM/POLARIS S315 (K924639)Adac Laboratories1993-01-15
MICROSPORIDIUM CONTROL SLIDE (K924893)Scientific Device Laboratory, Inc.1993-01-15
LC STRIP (K923358)Genetic Laboratories Wound Care, Inc.1993-01-13
KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN (K925748)Kendall Healthcare Products Co. Div.Of Tyco Health1993-01-13
DENTURE PRODUCT X (K914257)Essential Dental Systems, Inc.1993-01-13
TURKEL ABDOMINAL PARACENTESIS SYSTEM (K924702)Symbiosis Corp.1993-01-12
ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET (K925533)Angeion Corp.1993-01-12
ACCUFLATE (K924273)Instrumed, Inc.1993-01-12
TRACE MODEL# 840, 841,842 & 845 ARM BOARD (K925502)Trace Medical Equipment, Inc.1993-01-12
CURITY CALCIUM ALGINATE WOUND DRESSING (K925001)Kendall Healthcare Products Co. Div.Of Tyco Health1993-01-11
AIA-PACK PRL CALIBRATION VERIFICATION TEST SET (K924856)Tosoh Medics, Inc.1993-01-11
DYNAREX SUCTION CATHETERS & KITS (K922843)Dynarex Corp.1993-01-11
CFR MONOGRAPH (K925259)Combe, Inc.1993-01-11
DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD (K924493)Casco Standards1993-01-11
GAUZE SPONGES (K924650)Dav-Mar Medical Products, Inc.1993-01-11
ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET (K924852)Tosoh Medics, Inc.1993-01-11
EBV-VCA IGG ELISA TEST SYSTEM (K924091)Zeus Scientific, Inc.1993-01-11
UPSHERSCOPE(TM) (K922275)Upsher Laryngoscope Co.1993-01-06
RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY (K922801)Light Diagnostics1993-01-06
DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT (K924674)Genzyme Corp.1993-01-06
DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III (K926046)Baxter Diagnostics, Inc.1993-01-05
BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY (K924006)Baxter Healthcare Corp1992-12-29
MICROWAVE AUTOMATED TISSUE PROCESSOR (K924590)Innovative Medical Systems, Inc.1992-12-29
ACUFEX INTRA ARTICULAR MEASURING DEVICE (K925335)Acufex Microsurgical, Inc.1992-12-29
AIA-PACK HCG CALIBRATION VERIFICATION TEST SET (K924862)Tosoh Medics, Inc.1992-12-28
CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 (K926015)Cala Diagnostics1992-12-28
RUBBER DAM CLAMP (K923163)Aseptico, Inc.1992-12-28
DETECTABUSE(TM) (K925586)Biochemical Diagnostic, Inc.1992-12-28
ELECTROPHORESIS TANK (K924020)The Binding Site, Ltd.1992-12-28
SONEX ULTRASONIC TOOTH BRUSH (K913724)Sonex Intl., Corp.1992-12-28
PHILIPS SUPER CP FAMILY (K925844)Philips Medical Systems, Inc.1992-12-28
PHILIPS MEDIO CP FAMILY (K925105)Philips Medical Systems, Inc.1992-12-28
ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM (K925705)Denar Corp.1992-12-28
AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET (K924853)Tosoh Medics, Inc.1992-12-28
TRANSYSTEM LIQUID STUART MEDIUM (K924331)Pro-Lab Diagnostics1992-12-24
AUTOPOLE REGULATOR SYSTEM (K924999)Escalon Trek Medical1992-12-24
TRANSYSTEM AMIES WITH CHARCOAL (K924330)Pro-Lab Diagnostics1992-12-24
TRANSYSTEM LIQUID AMIES MEDIUM (K924328)Pro-Lab Diagnostics1992-12-24
TRANSYSTEM AMIES W/O CHARCOAL (K924329)Pro-Lab Diagnostics1992-12-24
LPIA-FERRITIN ASSAY (K924186)Seradyn, Inc.1992-12-23
INFINITY MICRO IRRIGATOR (K924052)Infinity Surgical Technology, Inc.1992-12-23
INSERT, OPTICAL, CHEMICAL BIOLOGICAL MASK (K921632)Lawrence Technologies, Inc.1992-12-23
NICHOLS APO B CHEMILUMINESCENCE ASSAY (K925702)Nichols Institute Diagnostics1992-12-23
.016' X .016 NICKEL TITANIUM UPRIGHTING SPRING (K923836)Ultimate Wireforms, Inc.1992-12-23
RED DOT 2515 CARDIAC SENSOR SYSTEM (K924487)3M Health Care, Ltd.1992-12-23
HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270 (K922437)Dabi-Atlante America Corp.1992-12-21
PM2002 PROLINE, PM2002 PROLINE EC (K923461)Planmeca USA, Inc.1992-12-21
DELIGHT (K923462)Planmeca USA, Inc.1992-12-21
STYLET AND TRACHEAL LIGHTWAND (STL) (K922842)Laerdal California, Inc.1992-12-18
SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 (K924915)Helena Laboratories1992-12-18
OLYMPUS IRON REAGENT (K924691)Olympus Corp.1992-12-18
BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC (K925716)Bennett X-Ray Corp.1992-12-17
BLOOD GAS MIXTURE (K924795)Gulf States Airgas1992-12-17
LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3 (K925151)Bio-Rad1992-12-17
LUNG DIFFUSION GAS MIXTURE (K924796)Gulf States Airgas1992-12-17
KODAK EKTASCAN SP CASSETTE (K925997)Eastman Kodak Company1992-12-17
CENTURION DISPOSABLE INSTRUMENTS (K923812)Tri-State Hospital Supply Corp.1992-12-17
BARD LEG BAG HOLDER (K926035)C.R. Bard, Inc.1992-12-17
POLYDOROS XS50 AND SX80 (K923786)Siemens Medical Solutions USA, Inc.1992-12-17
LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR (K911731)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-12-15
PATIENT EXAM GLOVES (POWDER FREE) (K923967)American Health Products, Inc.1992-12-15
BONE MARROW BIOPSY SYSTEM (K923872)The Straumann Co.1992-12-15
BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE (K924753)Bioenterics Corp.1992-12-15
ULTRALON POWDERFREE SURGICAL GLOVES (K915218)Johnson & Johnson Medical, Inc.1992-12-15
SUTURE REMOVAL KIT (K922339)Transidyne General Corp.1992-12-11
2ND SKIN STERILE ADHESIVE STRIP (K922228)Spenco Medical Corp.1992-12-11
CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER (K920876)Medtech Intl., Inc.1992-12-11
WATERS(TM) 996 PDA (K924347)Millipore Corp.1992-12-11
LYRIS 100/120 LABORATORY INFORMATION SYSTEM (K923844)Biovation, Inc.1992-12-11
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