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
166849–166872 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1980
TOPICAL COOLING DEV. TCD. #27-999
K800717 · DTR
Cobe Laboratories, Inc.
Cardiovascular · 16d
Cleared Apr 16, 1980
AMES LAB MANAGEMENT SYSTEM
K800724 · JQP
Miles Laboratories, Inc.
Microbiology · 15d
Cleared Apr 16, 1980
GOODE T-TUBE, BIOLITE COATED SILICONE/TU
K800727 · ETD
Xomed, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 16, 1980
PAPARELL TYPE 2, BIOLITE COATED SILI-
K800728 · ETD
Xomed, Inc.
Ear, Nose, Throat · 15d
Cleared Apr 16, 1980
PROLACTIN RIA KIT
K800740 · CFT
Amersham Corp.
Chemistry · 13d
Cleared Apr 16, 1980
CENTRAL VEIN CATHETERIZATION KIT
K800741 · DQO
Medical Components, Inc.
Cardiovascular · 13d
Cleared Apr 16, 1980
TOBRAMYCIN RIA KIT
K800743 · KLB
Antibodies, Inc.
Toxicology · 13d
Cleared Apr 16, 1980
DUNRICH TABLES
K800756 · ETF
Dunrich, Inc.
Ear, Nose, Throat · 12d
Cleared Apr 10, 1980
413A NEONATAL MONITOR
K800164 · FLS
Xerox Corp.
Anesthesiology · 76d
Cleared Apr 10, 1980
D668 & D664 CENTRAL MONITORING SYSTEMS
K800243 · DRT
Medtel Pty. , Ltd.
Cardiovascular · 65d
Cleared Apr 10, 1980
ANTERIOR & POST. RESTORATIVE PASTE SYS.
K800389 · KLE
American Dental Research
Dental · 50d
Cleared Apr 10, 1980
ANT. & POST. RESTORATIVE POWDER LIQ.
K800390 · KLE
American Dental Research
Dental · 50d
Cleared Apr 10, 1980
PAINT-ON-RESTORATIVE W/FISSURE SEALER
K800391 · EBC
American Dental Research
Dental · 50d
Cleared Apr 10, 1980
BRACKET BONDING SYSTEM METAL & PLASTIC
K800392 · DYH
American Dental Research
Dental · 50d
Cleared Apr 10, 1980
POLY SULFIDE IMPRESSION PASTE W/CATALYST
K800393 · ELW
American Dental Research
Dental · 50d
Cleared Apr 10, 1980
LUNDIA PLATE DISP.
K800424 · FJG
Gambro, Inc.
Gastroenterology & Urology · 44d
Cleared Apr 10, 1980
PORTABLE MEDICAL ULTRASOUND SCANNER
K800434 · IYO
Bion Ent., Ltd.
Radiology · 43d
Cleared Apr 10, 1980
PFIZER/AS&E 0450 LOCALIZER
K800501 · JDX
Pfizer Medical Systems, Inc.
Radiology · 37d
Cleared Apr 10, 1980
S.K. DIAG. ULTRASND. SMALL PARTS SCAN
K800531 · IYO
Smithkline Diagnostics, Inc.
Radiology · 34d
Cleared Apr 10, 1980
S.K. DIAG. ULTRASOUND BODY SCANNER
K800532 · IYO
Smithkline Diagnostics, Inc.
Radiology · 34d
Cleared Apr 10, 1980
MODEL TRIEX-L HOLLOW FIBER DIALYZER
K800549 · FJI
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 31d
Cleared Apr 10, 1980
MULTI-FORMAT SFD MODEL 1720
K800554 · IXL
Philips Medical Systems (Cleveland),...
Radiology · 29d
Cleared Apr 10, 1980
HYDRAGAMMA 16
K800601 · JJJ
Innotron of Oregon, Inc.
Chemistry · 24d
Cleared Apr 10, 1980
CK ISOENZYME ELECTROPHORESIS CONTROL-I.D
K800604 · JJT
Beckman Instruments, Inc.
Chemistry · 24d