FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
83809–83832 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 2000
STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
K993239 · HAW
Stryker Corp.
Neurology · 113d
Cleared Jan 18, 2000
OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
K993574 · LNH
Toshiba America Mri, Inc.
Radiology · 89d
Cleared Jan 18, 2000
DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL...
K993599 · LMA
Vidar Systems Corp.
Radiology · 85d
Cleared Jan 18, 2000
FAS ENDOLUMINAL BRUSH
K993614 · LJS
Fas Medical , Ltd.
General Hospital · 85d
Cleared Jan 18, 2000
RENAMEL SCULPT
K993658 · EBF
Cosmedent, Inc.
Dental · 81d
Cleared Jan 18, 2000
RENAMEL PACK
K993659 · EBF
Cosmedent, Inc.
Dental · 81d
Cleared Jan 18, 2000
CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
K993720 · KNQ
Cordis Corp.
Gastroenterology & Urology · 76d
Cleared Jan 18, 2000
SHARPVIEW IMAGE ENHANCEMENT SYSTEM
K993802 · LLZ
Context Vision AB
Radiology · 70d
Cleared Jan 18, 2000
LUMAGEM SCINTILLATION CAMERA
K993813 · IYX
Gamma Medica
Radiology · 69d
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