FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
83305–83328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2000
TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES
K993847 · LYZ
Longbest (Xiamen) Balls Co., Ltd.
General Hospital · 67d
Cleared Jan 18, 2000
TEH LOONG VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVE
K993849 · LYZ
Longbest (Xiamen) Balls Co., Ltd.
General Hospital · 67d
Cleared Jan 18, 2000
UNSCENTED INTERLABIAL MENSTRUAL PAD
K993870 · HHD
Procter & Gamble Co.
Obstetrics & Gynecology · 64d
Cleared Jan 18, 2000
ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17
K993920 · DIC
Diagnostic Chemicals , Ltd.
Toxicology · 61d
Cleared Jan 18, 2000
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
K993928 · DEW
Wako Chemicals USA, Inc.
Immunology · 61d
Cleared Jan 18, 2000
LITESABER 2000
K993942 · GEX
Laser Dental Innovations
General & Plastic Surgery · 60d
Cleared Jan 18, 2000
SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
K993984 · LDJ
Syva Co.
Toxicology · 55d
Cleared Jan 18, 2000
PHASED ARRAY KNEE AND FOOT COIL
K994040 · MOS
Usa Instruments, Inc.
Radiology · 50d
Cleared Jan 18, 2000
RHIGENE ANA ELISA TEST SYSTEM
K994071 · LJM
Rhigene, Inc.
Immunology · 47d
Cleared Jan 18, 2000
SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES
K994081 · KGO
Safeskin Corp.
General Hospital · 46d
Cleared Jan 18, 2000
LATEX CONDOM
K994095 · HIS
Thai Nippon Rubber Industry Co., Ltd.
Obstetrics & Gynecology · 46d
Cleared Jan 18, 2000
HARDYDISK IMIPENEM, 10MCG
K994132 · JTN
Hardy Diagnostics
Microbiology · 42d
Cleared Jan 18, 2000
ACCESS HYBRITECH PSA QC, MODEL 37209
K994200 · JJX
Beckman Coulter, Inc.
Immunology · 36d
Cleared Jan 18, 2000
ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
K994330 · GXY
Aspect Medical Systems, Inc.
Neurology · 26d
Cleared Jan 18, 2000
ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES
K994333 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 26d
Cleared Jan 18, 2000
CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL
K994427 · GEX
Cynosure, Inc.
General & Plastic Surgery · 19d
Cleared Jan 18, 2000
CYNOSURE PHOTOGENICA SPIR
K994437 · GEX
Cynosure, Inc.
General & Plastic Surgery · 19d
Cleared Jan 14, 2000
MICROSTREP PLUS PANEL, VANCOMYCIN
K983953 · JWY
Dade Microscan, Inc.
Microbiology · 435d
Cleared Jan 14, 2000
INFRARED EAR THERMOMETER, MODEL KI-8120
K984551 · FLL
K-Jump Health Co., Ltd.
General Hospital · 388d
Cleared Jan 14, 2000
VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K991916 · FIP
Virginia Water Systems, Inc.
Gastroenterology & Urology · 221d
Cleared Jan 14, 2000
PHARMASEED, MODEL BT-103-1
K992007 · KXK
Syncor Pharmaceuticals, Inc.
Radiology · 213d
Cleared Jan 14, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
K992684 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 157d
Cleared Jan 14, 2000
ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
K992749 · MSX
Spacelabs Medical, Inc.
Cardiovascular · 151d
Cleared Jan 14, 2000
IBC FLOGUARD, MODEL 6050
K992785 · MJJ
International Biophysics Corp.
Cardiovascular · 148d