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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
142585–142608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 1986
ACROMED ADS BONE NAIL
K862552 · KTW
Buckman Co., Inc.
Orthopedic · 61d
Cleared Sep 02, 1986
AMBER-CHEST
K862616 · KPR
Old Delft Corp. of America
Radiology · 55d
Cleared Sep 02, 1986
CONCEPT ARTHROSCOPY RASP
K862659 · HTP
Concept, Inc.
Orthopedic · 50d
Cleared Sep 02, 1986
2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP
K862689 · HXX
W.L. Gore & Associates, Inc.
Orthopedic · 49d
Cleared Sep 02, 1986
REXILLIUM N. B. F.
K862822 · EJH
Jeneric Ind.
Dental · 39d
Cleared Sep 02, 1986
KEISEI SURGICAL BLADES (STERILE & NON-STERILE)
K863211 · GES
Keisei Medical Industrial Co., Ltd.
General & Plastic Surgery · 13d
Cleared Sep 02, 1986
KEISEI HANDLES FOR SURGICAL BLADES
K863212 · GDZ
Keisei Medical Industrial Co., Ltd.
General & Plastic Surgery · 13d
Cleared Sep 02, 1986
KEISEI SCALPEL (STERILE AND NON-STERILE)
K863213 · GDX
Keisei Medical Industrial Co., Ltd.
General & Plastic Surgery · 13d
Cleared Sep 02, 1986
KEISEI MICRO-BLADES (STERILE AND NON-STERILE)
K863214 · GES
Keisei Medical Industrial Co., Ltd.
General & Plastic Surgery · 13d
Cleared Sep 02, 1986
MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM
K863274 · HIB
Martin Medical
Obstetrics & Gynecology · 8d
Cleared Sep 02, 1986
MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM
K863275 · HIB
Martin Medical
Obstetrics & Gynecology · 8d
Cleared Sep 02, 1986
SURGI-WIPES
K863278
Dermacare Products, Inc.
General & Plastic Surgery · 8d
Cleared Aug 29, 1986
J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS
K860678 · JYS
Jay Kenny Templeton
Ear, Nose, Throat · 185d
Cleared Aug 29, 1986
GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET
K860682 · CGA
Gambro, Inc.
Chemistry · 185d
Cleared Aug 29, 1986
SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC
K861708 · JAK
General Electric Co.
Radiology · 116d
Cleared Aug 29, 1986
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER
K862005 · EWG
Laserscope
Ear, Nose, Throat · 94d
Cleared Aug 29, 1986
DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR
K862119 · DYG
Parke-Davis Co.
Cardiovascular · 87d
Cleared Aug 29, 1986
OMC ORTHOMET CANNULATED SCREW
K862157
Orthomet, Inc.
Orthopedic · 85d
Cleared Aug 29, 1986
WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW
K862230 · HWC
Buckman Co., Inc.
Orthopedic · 79d
Cleared Aug 29, 1986
CIBA CORNING MAGIC LITE TSH IMMUNOASSAY
K862407 · JLW
Ciba Corning Diagnostics Corp.
Chemistry · 65d
Cleared Aug 29, 1986
SCHNEIDER-SHILEY FLUSHING CATHETER
K862466 · DQO
Shiley, Inc.
Cardiovascular · 60d
Cleared Aug 29, 1986
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV
K862540 · DWD
Gish Biomedical, Inc.
Cardiovascular · 58d
Cleared Aug 29, 1986
AVL MODEL 984 ELECTROLYTE ANALYZER
K862819 · JGS
Avl Scientific Corp.
Chemistry · 36d
Cleared Aug 29, 1986
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
K862845 · LBS
Em Diagnostic Systems, Inc.
Chemistry · 31d