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

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RecordFirmDate
ARTIFLEX(TM) (K910274)Beiersdorf, Inc.1991-03-05
FORTRESS CUSTOM MANUAL FOLDING WHEELCHAIR (K910750)Fortress Litestyle1991-03-05
FORTRESS LIBERTY MANUAL FOLDING WHEELCHAIR (K910752)Fortress Litestyle1991-03-05
PROCEDURE KIT/ROUTINE DENTAL PROCEDURES (K905461)Angiosystems, Inc.1991-03-05
FORTRESS FREESTYLE II MANUAL FOLDING WHEELCHAIR (K910746)Fortress Litestyle1991-03-05
DELUXE SANITARY PAD (K905178)American Healthcare Corp.1991-03-04
NEON RUBBER SUNGLASSES (K905183)Ha-Lo Advertising Specialties, Inc.1991-03-04
GDS ENZYMATIC B-HYDROXYBUTYRATE REAGENT MODIFIED (K910108)Gds Diagnostics1991-03-04
VARIOUS MALE QUICK CONNECTS. (K905091)Medical Fittings, Inc.1991-03-04
ACTIVE MODEL AMC MINI CANAL ITE HEARING AID (K910704)Active Electronics, Inc.1991-02-28
ACTIVE MODEL AHX HELIX ITE HEARING AID (K910705)Active Electronics, Inc.1991-02-28
PHILIPS MODEL S46-O BTE HEARING AID (K910744)Philips Hearing Instruments Co.1991-02-28
3M MODEL 8245 ITE HEARING AID (K910763)3M Company1991-02-28
ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID (K910701)Active Electronics, Inc.1991-02-28
ACTIVE MODEL AHS HALF SHELL ITE HEARING AID (K910702)Active Electronics, Inc.1991-02-28
POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC (K910018)Phonak, Inc.1991-02-28
PHONAK MODEL PICO C-S-H-T, BTE HEARING AID (K910012)Phonak, Inc.1991-02-28
PHILIPS MODEL S46-OL BTE HEARING AID (K910743)Philips Hearing Instruments Co.1991-02-28
3M MODEL 8243 ITE HEARING AID (K910761)3M Company1991-02-28
ACTIVE MODEL AST CUSTOM ITE HEARING AID (K910700)Active Electronics, Inc.1991-02-28
3M MODEL 8244 ITE HEARING AID (K910762)3M Company1991-02-28
ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID (K910703)Active Electronics, Inc.1991-02-28
3M MODEL 8242 ITE HEARING AID (K910760)3M Company1991-02-28
3M MODEL 8241 ITE HEARING AID (K910759)3M Company1991-02-28
PHOSPHORUS (INORGANIC) TEST SYSTEM (K910296)Biochemical Trade, Inc.1991-02-27
COBAS ALPHA (K910222)Roche Diagnostic Systems, Inc.1991-02-27
DISPOSABLE INTRODUCER SHEATH (K910079)Applied Vascular Devices, Inc.1991-02-27
MODIFIED SITE PERISTALTIC FOOTSWITCH (K905620)Site Microsurgical Systems, Inc.1991-02-27
LAP DISCS (K905472)Carr-Scarborough Microbiologicals, Inc.1991-02-27
MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM (K904501)Medical Diagnostic Technologies, Inc.1991-02-26
GGT REAGENT (K905618)Amresco, Inc.1991-02-26
ECLIPSE ICA CHOLESTEROL (K905145)Biotope, Inc.1991-02-26
J&B OPTICAL FRAMES (K910626)J & B Optical, Inc.1991-02-26
SUNGLASSES (K902343)Jasco Products Co., Inc.1991-02-26
VITREORETINAL INFUSION CANNULA (K904074)Visitec Co.1991-02-26
HFQ SERIES CONTROLS AND GENERATORS (K905799)Bennett X-Ray Corp.1991-02-26
SLIDEX ROTA-KIT 2 (K895805)Vitek Systems, Inc.1991-02-26
M. CAT. BUTYRATE DISC (K905666)Carr-Scarborough Microbiologicals, Inc.1991-02-26
CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST (K910240)Crystal Diagnostics, Inc.1991-02-26
PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES) (K905765)Tillotson Rubber Co., Inc.1991-02-25
FOXELL PLUS MULTIPLE (PERSONAL TOUCH TM) (K910439)Lowenkamp Intl., Inc.1991-02-25
CK-MB IMMUNOASSAY CONTROL (K905623)Seradyn, Inc.1991-02-22
ECLIPSE ICA ANALYZER (K910302)Biotope, Inc.1991-02-22
PREP AND OPERATING STAND (K905564)Mcconnell Orthopedic1991-02-21
EBV IGM ELISA TEST (K910042)Gull Laboratories, Inc.1991-02-21
LATERAL BUTTRESS SUPPORT (K905565)Mcconnell Orthopedic1991-02-21
NITRATE DISK (K905163)Remel Co.1991-02-20
ASEPTIMINI UNIT, ADU-10 (K905401)Aseptico, Inc.1991-02-20
VPW 2903 A-1 -208V, B2-440V,C3-240V X-RAY SUPPLY (K904169)Varian Canada, Inc.1991-02-19
ROMFLEX (K905718)Paraflex Corp.1991-02-19
RICHARD-ALLAN CLAMP COVERS (K905682)Richard-Allan Medical1991-02-19
SOM 6V (K910357)Jedmed Instrument Co.1991-02-19
ACCUFLATE (K910512)Instrumed, Inc.1991-02-19
DIGIFLEX, LATEX PATIENT EXAMINATION GLOVES (K910542)21st Century Group1991-02-19
PERIO PIK (K905188)Teledyne Water Pik1991-02-15
EYE SEE INSTRUMENT (K905237)King Tool, Inc.1991-02-14
VPW2877E7 X RAY POWER SUPPLY (K905855)Varian Canada, Inc.1991-02-13
STRATUS ESTRADIOL FLUOREMETRIC ENZYME (K910249)Baxter Healthcare Corp1991-02-13
PRIMARY MANUFACTURER SUNGLASSES (K903065)Mao Lin Ent.1991-02-13
HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES (K905155)Star Dental Mfg. Co.1991-02-13
CHILDREN SUNGLASSES (K910141)Consolidated Stores Intl. Corp.1991-02-13
G.E. DXD 325/350/350II/DXD 525/525II GENERATORS (K902986)Electromek Diagnostic Systems, Inc.1991-02-13
BONE PAD REMOVER (K910225)Acra Cut, Inc.1991-02-12
PATIENT EXAM GLOVES(MFG: YUNG CHIEH ENTERPRISE) (K904839)Up TO Date, Inc.1991-02-12
EXIT ALARM (K905421)Alertcare1991-02-12
DURAL DISSECTORS (K910226)Acra Cut, Inc.1991-02-12
APOLLO MOBILE SCALE (K905061)Apollo Enterprise, Ltd. Co.1991-02-12
PATIENT EXAMINATION GLOVES (K910442)Asian Latex, Ltd.1991-02-12
PVC ROUND WOUND DRAINS (K905422)Axiom Medical, Inc.1991-02-11
AQUA-GARD WATERPROOF WOUND PATCH (K905022)Bellhouse Medical, Inc.1991-02-11
VESSELOOPS (K905240)Sparta Surgical Corp.1991-02-06
PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (K905462)Angiosystems, Inc.1991-02-06
SENSIDERM (K904244)Ansell Intl.1991-02-06
INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM (K905365)Instrument Makar, Inc.1991-02-06
SKIN MARKER (K905143)Aesculap, Inc.1991-02-06
CUP OUT (K905027)Anspach Mfg., Inc.1991-02-05
PHILIPS MODEL S47 BTE HEARING AID (K910206)Philips Hearing Instruments Co.1991-02-05
SUNGLASSES (K905041)Eskco, Inc.1991-02-05
ELECTRAPETTE (R) (K910140)Matrix Technologies Corp.1991-02-04
GAMMA 600 NUCLEAR MEDICINE COMPUTER (K903469)Strichman Medical Equipment, Inc.1991-02-04
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE) (K910143)Eastman Kodak Company1991-02-04
LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY (K905814)London Diagnostics, Inc.1991-02-04
BIOTROL BILIRUBIN C & T CONTROL (K905280)Biotrol, USA, Inc.1991-02-04
CIBA CORNING ACS LH IMMUNOASSAY (K910198)Ciba Corning Diagnostics Corp.1991-02-04
OLYMPUS URINE PH (K905146)Diagnostic Systems1991-02-04
IODOSORB GEL (K905069)Perstorp AB C/O Robert Joel Slomoff1991-01-31
SURGICARE STERILE SURGICAL GLOVES (K904972)Kanam Latex Industries Pvt. , Ltd.1991-01-31
ORAL PHARYNGEAL CLEANSING DEVICE (K905011)Concord/Portex1991-01-31
VINYL GLOVE-POWEDERFREE (OBERON GLOVES INTL. LTD) (K903847)Zest Mark Industrial Co., Ltd.1991-01-31
JAIN SUTURE/VESIBAND ORGANIZER (K905105)Jain Surgical Equipment, Inc.1991-01-31
GAMMA-GLUTAMYL TRANSFERASE DETERMINATION (K905649)Biochemical Trade, Inc.1991-01-30
PM2002 CC AND PM2002 EC (K904948)Planmeca USA, Inc.1991-01-30
STAT(TM) GLOVE (K905177)Success Builders Intl., Inc.1991-01-30
LATEX GLOVE APPLICATION AND REMOVAL SYSTEM (K905127)Success Builders Intl., Inc.1991-01-30
MERISTAR-MP (K905493)Meridian Diagnostics, Inc.1991-01-30
DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS (K905829)Kamiya Biomedical Co.1991-01-30
DANNIFLEX MODEL 500TM CPM (K904735)Buckman Co., Inc.1991-01-30
AM130 AGC-O (BEHIND THE EAR) HEARING AID (K910148)Electone, Inc.1991-01-29
ELECTONE BTE MODEL AM 130 PP (K910101)Electone, Inc.1991-01-29
ELECTONE BTE MODEL AM 240 HF (K910099)Electone, Inc.1991-01-29
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Every clearance here is in the API, with alerts when new ones post.