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
158953–158976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1982
K30000 DENTAL CHAIR
K822740 · KLC
Kaycor Intl., Ltd.
Dental · 19d
Cleared Sep 28, 1982
U.V.A.C. CURETTES
K822756 · HHD
American Hospital Supply Corp.
Obstetrics & Gynecology · 19d
Cleared Sep 28, 1982
ARTERIAL LINE KIT
K822760 · FMF
Martell Medical Products, Inc.
General Hospital · 14d
Cleared Sep 24, 1982
THREE SECOND THERMOMETER #TS-1000
K820948 · FLL
Temp-Stik Corp.
General Hospital · 171d
Cleared Sep 24, 1982
BE#6006 VAR. RESIS. INSPIR. MUSCLE
K821492 · BWF
Instrumentation Industries, Inc.
Anesthesiology · 129d
Cleared Sep 24, 1982
RETRIEVAL BALLOONS
K821818 · KOD
American Endoscopy, Inc.
Gastroenterology & Urology · 95d
Cleared Sep 24, 1982
CADWELL 7400
K822214 · GWF
Cadwell Laboratories, Inc.
Neurology · 60d
Cleared Sep 24, 1982
THERMOTHERAPY
K822217 · LKX
Luther Medical Products, Inc.
Gastroenterology & Urology · 60d
Cleared Sep 24, 1982
ADHESIVE SPRAY #4050-4060
K822307 · KNX
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 52d
Cleared Sep 24, 1982
THE 3500
K822396 · GWF
Tracor Northern, Inc.
Neurology · 45d
Cleared Sep 24, 1982
VASOGRAPH, MODEL MV-2
K822455 · DSB
Electro-Diagnostic Instruments
Cardiovascular · 39d
Cleared Sep 24, 1982
DISPOSABLE THERMOMETERS
K822502 · FLK
Hudson Oxygen Therapy Sales Co.
General Hospital · 32d
Cleared Sep 24, 1982
NEUROMEDICS ORIONS #660-01
K822600 · GZJ
Intermedics, Inc.
Neurology · 28d
Cleared Sep 24, 1982
LINEGUARD CATHETER SHIELD MODEL 100
K822732 · KMK
Ray-Marshall Laboratory
General Hospital · 16d
Cleared Sep 24, 1982
TRIEX-IH DIALYZER
K822738 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 15d
Cleared Sep 24, 1982
SOLID STATE CONTINUOUS FLOW CONTROL
K822743 · LJH
Widran Urological Group, Ltd.
Gastroenterology & Urology · 14d
Cleared Sep 22, 1982
MYO-TONE, INC. SYSTEM-80
K822250 · IPF
Myo-Tone, Inc.
Physical Medicine · 57d
Cleared Sep 22, 1982
DISPOSABLE PLASTIC TRANSFUS./INFUS. ASSB
K822354 · FPA
Valleylab, Inc.
General Hospital · 47d
Cleared Sep 22, 1982
DISP. METAL & PLASTIC ELECTROSURG. DEV
K822355 · GEI
Valleylab, Inc.
General & Plastic Surgery · 47d
Cleared Sep 22, 1982
MEDI-THERM SKIN THERMOMETER
K822435 · FLL
Everest Interscience, Inc.
General Hospital · 40d
Cleared Sep 22, 1982
MASTER I
K822696 · INI
Master Medical Services, Inc.
Physical Medicine · 15d
Cleared Sep 21, 1982
LEGIONELLA PNEUMOPHILA
K822066 · LHL
Biodan Medical Systems, Ltd.
Microbiology · 69d
Cleared Sep 21, 1982
CAMERON-MILLER #40-1516
K822092 · GEI
Cameron-Miller, Inc.
General & Plastic Surgery · 67d
Cleared Sep 21, 1982
STAT-SCAN
K822093 · DXG
Survival Technology, Inc.
Cardiovascular · 67d