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

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RecordFirmDate
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM (K894252)Bio-Rad1989-08-01
RAICHEM(TM) SPIA(TM) IGG REAGENTS (K894416)Reagents Applications, Inc.1989-08-01
LATEX EXAMINATION GLOVES (K893262)S.C. Rubber Co., Ltd.1989-08-01
STERIL-DERM TRANSPARENT WOUND DRESSING (K892837)Biointerface Technologies, Inc.1989-08-01
LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3 (K891475)Bio-Rad1989-08-01
HYGEIA EXAMINATION GLOVES (K891804)Rubtex , Ltd.1989-07-31
ESSEREL PATIENT EXAMINATION GLOVES (LATEX) (K891494)Karthik Engineering, Inc.1989-07-31
PATIENT EXAMINATION GLOVES (LATEX) (K891668)Influx Pacific Sdn. Bhd.1989-07-31
PATIENT EXAMINATION GLOVES (LATEX) (K891809)Firestone Financial Corp.1989-07-31
PATIENT EXAMINATION GLOVES (LATEX) (K891629)Union Rubber Gloves Co., Ltd.1989-07-31
PROSON PATIENT EXAMINATION GLOVES (K893076)Long Far Industry Co., Ltd.1989-07-31
PATIENT EXAMINATION GLOVES (LATEX) (K891808)Anro Corp. Sdn Bhd1989-07-31
PATIENT EXAMINATION GLOVES (LATEX) (K891665)Clinical Supply1989-07-31
PATIENT EXAMINATION GLOVES (LATEX) (K891340)Partech Co., Inc.1989-07-31
VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX) (K890968)Interpro Intl., Inc.1989-07-31
LATEX EXAM GLOVES (MFG. GUANGDONG ZHONGSHAN) (K893143)Guangzhou Chemicals Import & Export Corp.1989-07-31
PATIENT EXAM GLOVES (LATEX) MFG. CHINA XINXING (K891496)B.C. Young Intertrade Corp.1989-07-31
PATIENT EXAMINATION GLOVES (LATEX) (K891787)Socoil Latex Products Sdn Bhd1989-07-31
PATIENT EXAMINATION GLOVES (LATEX) (K891285)Buildvest Holdings Sdn Bhd1989-07-31
LATEX EXAM GLOVES (MFG. GUANGZHOU NO. 11 RUBBER) (K893144)Guangzhou Chemicals Import & Export Corp.1989-07-31
LONGFORTUNE PATIENT EXAM GLOVES (K892980)Long Fortune Industries , Ltd.1989-07-31
PATIENT EXAMINATION GLOVES (LATEX) (K891747)Arden Sales, Inc.1989-07-31
PATIENT EXAMINATION GLOVES (LATEX) (K891495)Salcon Rubber Sdn Bhd1989-07-31
PATIENT EXAM GLOVES (LATEX) MFG. HUA GUANG (K891497)B.C. Young Intertrade Corp.1989-07-31
LATEX EXAMINATION GLOVES (K894195)Jiahn Chiaur Enterprise Co., Ltd.1989-07-28
PATIENT EXAMINATION GLOVES (LATEX) (K891246)Penfirst Corp. Sdn. Bhd.1989-07-28
PATIENT EXAMINATION GLOVES (LATEX) (K891505)Taiwan Link Sdn Bhd1989-07-28
MEDI, ULTRA, CURI EXAM GLOVES (K893057)Sinjaca Inc. Dba Sic Medical & Surgical Supplies1989-07-28
PATIENT EXAMINATION GLOVES (LATEX) (K892606)Tritech Mfg. Industries, Inc.1989-07-28
SURGICARE (R) SPECIALTY EXAMINATION GLOVES (K893756)Inter Continental Health Care1989-07-28
PATIENT EXAMINATION GLOVES (LATEX) (K892016)Winhace Trading, Inc.1989-07-28
NON-STERILE LATEX EXAMINATION GLOVES (K892461)Rahn Laboratories1989-07-28
LATEX EXAMINATION GLOVES (K893825)Frank W. Winne & Son, Inc.1989-07-28
PATIENT EXAM GLOVES (MFG. HEBEI XINJI & XINJI WEN) (K891862)China Xinxing Corp. , Ltd.1989-07-28
PATIENT EXAM GLOVES (MFG. UNITED LION RUBBER) (K892489)Chori America, Inc.1989-07-28
PATIENT EXAMINATION GLOVES (LATEX) (K891275)M.R. Rubber Industries Sdn. Bhd.1989-07-28
PATIENT EXAM GLOVES (MFG. TIANJIN & JINGJIN) (K891861)China Xinxing Corp. , Ltd.1989-07-28
CONCOA PRESSURE REGULATORS (K893621)Concoa Controls Corp. of America1989-07-28
PACER R 9 TREADMILL (K893032)Pacer Industries, Inc.1989-07-27
ENABLER LIGHTWEIGHT MANUAL WHEELCHAIR (K894345)Damaco1989-07-27
TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES (K892930)Technicon Instruments Corp.1989-07-27
ABBOTT TESTPACK CHLAMYDIA (K893676)Abbott Laboratories1989-07-25
CHAIR/STOOL UNIT DENTAL OPER., PORTABLE, FIELD (K893454)Atlantic Industries, Inc.1989-07-25
DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM (K893775)E.I. Dupont DE Nemours & Co., Inc.1989-07-25
TECNOL SILK STRIP (K894205)Tecnol New Jersey Wound Care, Inc.1989-07-25
NEW WEST SUNGLASSES (K893986)New West Promotions1989-07-25
GENETIC SYSTEMS MICROPLATE READER (K891767)Genetic Systems Corp.1989-07-25
WORLD CHAIR (K894136)Invacare Corp.1989-07-25
HDL PRECIPITATING REAGENT (K893966)Diagnostic Systems1989-07-25
DAU I, DAU II, DAU III AND DAU IV CONTROL URINE (K893835)Ciba Corning Diagnostics Corp.1989-07-25
MODIFIED POLYCHROME IV STAIN (K894045)Devetec, Inc.1989-07-25
THORACENTISIS KIT (K894326)Mill-Rose Laboratory1989-07-24
SHUNT CONNECTORS (K893679)Akcess Medical Products, Inc.1989-07-24
LATEX EXAMINATION GLOVES (K893296)Midas Intl. Development Corp.1989-07-24
LATEX EXAMINATION GLOVES (K893864)In Medicine, Inc.1989-07-24
LATEX EXAMINATION GLOVES (K893295)Lee AH Sheng Ent. Co., Ltd.1989-07-24
VINYL PATIENT EXAMINATION GLOVES (K892575)Foodhandler, Inc.1989-07-24
MINICLINIC OVULATION PREDICTION TEST (K891762)Vanguard Biomedical Corp.1989-07-20
DADE LIPID-TROL (K893580)Baxter Healthcare Corp1989-07-20
J&S IRON SATURATING REAGENTS (K893662)J.S. Medical Assoc.1989-07-20
CENTRICON CONCENTRATOR (K893733)Amicon, Inc.1989-07-20
ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 (K893752)Em Diagnostic Systems, Inc.1989-07-20
THE POUCH GROIN & ABDOMINAL STRESS AID (K892379)Kuhn Industries1989-07-20
ALT REAGENT (PROCEDURE NUMBER 159) (K893560)Sigma Chemical Co.1989-07-20
RME 325R (K893674)Fischer Imaging Corp.1989-07-20
COBAS FARA CENTRIFUGAL ANALYZER (K893641)Roche Diagnostic Systems, Inc.1989-07-20
MAMM-AIRE CP (K893681)Custom Medical Products, Ltd.1989-07-20
GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 (K893765)Em Diagnostic Systems, Inc.1989-07-20
70-X/RVG (RADIOVISIOGRAPHY) (K881133)Trophy Radiologie1989-07-20
J1 ATTACHMENT (ORTHODONTIC APPLIANCE) (K891982)T.M.K. Dental Products1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892749)Industri Leva Sdn. Bhd.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892122)Wallgear Industrial Ltd. C/O Condor Financial1989-07-14
LATEX EXAM GLOVES (K893241)Semodal Jaya Sdn. Bhd.1989-07-14
PATIENT EXAM GLOVES (MFG. MOSS POINT GLOVE CO.) (K891940)Tillotson Corp.1989-07-14
VINYL EXAMINATION GLOVES (K891840)Maxcare, Inc.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892588)Dynamic Plantations Sdn Bhd1989-07-14
CARDIOCAP(TM) DR-104 REPORTER (K885058)Datex Division Instrumentarium Corp.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892271)Asma Rubber Products Pvt. , Ltd.1989-07-14
LATEX PATIENT EXAMINATION GLOVES (K891110)I Horng Industrial Co., Ltd.1989-07-14
ALAMTEX PATIENT EXAMINATION GLOVES (LATEX) (K891966)Concept Rubber Products Sdn Bhd1989-07-14
CHAMP-PAQ LATEX PATIENT EXAM GLOVES (K892097)Winmed Instruments Mfg. Corp.1989-07-14
LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL) (K890891)Interpro Intl., Inc.1989-07-14
PATIENT EXAMINATION GLOVES (K891284)Real Latex Pvt. , Ltd.1989-07-14
ANATOMICAL EXAMINATION GLOVES (K892579)Ansell Pacific, Inc.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892131)Five Lakes Co., Inc.1989-07-14
NIC BRAND PATIENT EXAMINATION GLOVES (K891963)Nikemark Tape Industrial Corp.1989-07-14
LATEX EXAMINATION GLOVES (K893551)Mlb Holdings Sdn. Bhd.1989-07-14
RUBBERCARE PATIENT EXAMINATION GLOVE (K891123)Perusahaan Pelindung Getah (M) Sdn Bhd1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892267)Ejs Sdn. Bhd.1989-07-14
NON-STERILE LATEX EXAMINATION GLOVES (K892993)Zeisin Industrial Co., Ltd.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892498)Yi Feng Industrial Co., Ltd.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892089)N.V. Kalibaru1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K891749)Ocean Pacific Med Tec1989-07-14
ITE PRESCRIPTION SERIES MODEL LP (K891915)Us Hearing Centers, Inc.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892468)Hwa Shun Rubber Ent. Co. , Ltd.1989-07-14
LATEX EXAMINATION GLOVES (K892326)Safety Supply House of Louisiana, Inc.1989-07-14
LATEX EXAMINATION GLOVES (K893352)Hua Shu-Yee Industrial Co., Ltd.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892015)China North Industries Corp.1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K892789)P.T. Indo Rama Synthetics1989-07-14
PATIENT EXAMINATION GLOVES (LATEX) (K891502)Rindumas Sdn Bhd1989-07-14
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Every clearance here is in the API, with alerts when new ones post.