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
74497–74520 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2002
IPLAN
K020631 · HAW
Brainlab AG
Neurology · 194d
Cleared Sep 09, 2002
WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET
K020972 · DHR
Wako Chemicals USA, Inc.
Immunology · 167d
Cleared Sep 09, 2002
ELECSYS CORTISOL TEST SYSTEM
K021218 · JFT
Roche Diagnostics Corp.
Chemistry · 145d
Cleared Sep 09, 2002
P4 PHYSIO
K022175 · IPF
Valmed Corp.
Physical Medicine · 68d
Cleared Sep 09, 2002
MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM...
K022182 · NBW
Abbott Laboratories
Chemistry · 68d
Cleared Sep 09, 2002
CRANIAL SYMMETRY SYSTEM
K022273 · MVA
Beverly Hills Prosthetics Orthotics,...
Neurology · 56d
Cleared Sep 09, 2002
NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
K022323 · HRS
Osteomedics, Inc.
Orthopedic · 54d
Cleared Sep 09, 2002
NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
K022325 · HRS
Osteomedics, Inc.
Orthopedic · 54d
Cleared Sep 09, 2002
BENJAMIN ENVOY PHACO HANDPIECE
K022833 · HQC
Benjamin Biomedical, Inc.
Ophthalmic · 14d
Cleared Sep 06, 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531 · MQV
Biomet, Inc.
Orthopedic · 477d
Cleared Sep 06, 2002
ARTHREX UNIVERS FRACTURE PROSTHESIS
K020345 · KWS
Arthrex, Inc.
Orthopedic · 217d
Cleared Sep 06, 2002
EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
K021278 · ODG
Pentax Precision Instrument Corp.
Radiology · 137d
Cleared Sep 06, 2002
G-2 VERSION 3, MODEL 10049
K021890 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 88d
Cleared Sep 06, 2002
G-MOPS, MODEL 10030
K021893 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 88d
Cleared Sep 06, 2002
G-MM, MODEL 10038
K021894 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 88d
Cleared Sep 06, 2002
HSA-SOLUTION, MODEL 10034/10064
K021896 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 88d
Cleared Sep 06, 2002
CALSCOR SOFTWARE
K021913 · LLZ
3D Med Co., Ltd.
Radiology · 87d
Cleared Sep 06, 2002
SYNTHES (USA) RESORBABLE FIXATION SYSTEM
K021928 · JEY
Synthes (Usa)
Dental · 86d
Cleared Sep 06, 2002
ENDOSCOPIC FIBEROPTIC CABLE
K021931 · HBI
Gulf Medical Fiberoptics
General & Plastic Surgery · 86d
Cleared Sep 06, 2002
SYNTHES 6.5 MM CANNULATED SCREW
K021932 · HWC
Synthes (Usa)
Orthopedic · 86d
Cleared Sep 06, 2002
THERMIQUE
K022097 · EAT
Parkell, Inc.
Dental · 71d
Cleared Sep 06, 2002
DIRECT BILIRUBIN
K022180 · CIG
Abbott Laboratories
Chemistry · 65d
Cleared Sep 06, 2002
SMARTSTITCH SUTURE DEVICE, MODEL OM-8500
K022229 · OCW
Opus Medical, Inc.
Gastroenterology & Urology · 58d
Cleared Sep 06, 2002
G-1 VERSION 3, MODEL 10048
K022244 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 56d