Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
153937–153960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1984
QBC CENTRIFUGAL HEMATOLOGY ANALYZ
K840658 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 62d
Cleared Apr 17, 1984
COR-TEMP-TEMP. MONITOR
K840675 · FLL
Product Research Organizations,Inc.
General Hospital · 62d
Cleared Apr 17, 1984
PORPHYRIN TEST AGAR
K840685 · JSF
Remel Co.
Microbiology · 62d
Cleared Apr 17, 1984
CIRCUIT BREATHING
K840740 · CAI
Marquest Medical Products, Inc.
Anesthesiology · 60d
Cleared Apr 17, 1984
GAST STAT MONITORING SYSTEM
K840749 · DTY
Cardiovascular Devices, Inc.
Cardiovascular · 54d
Cleared Apr 17, 1984
HAEMOFUGE A. BIOFUGE A. & B
K840767 · JPI
Heraeus-Christ GmbH
Hematology · 54d
Cleared Apr 17, 1984
MMG FOLEY CATHETER
K840839 · KOD
Medical Technologies of Georgia
Gastroenterology & Urology · 53d
Cleared Apr 17, 1984
POTASSIUM CHLORIDE TABLETS
K840843 · CHL
Bionostics, Inc.
Chemistry · 53d
Cleared Apr 17, 1984
PHADEBAS RAST TEST -ALLERGEN DISCS
K840876 · DHB
Pharmacia, Inc.
Toxicology · 50d
Cleared Apr 17, 1984
ARGYLE TAPERED VASCULAR SHUNT
K840914 · DWF
Sherwood Medical Co.
Cardiovascular · 48d
Cleared Apr 17, 1984
DIMIX CONTAINER FOR PARNETERAL NUTRIT
K840915 · KPE
Gil-Med Industries C/O Kegan & Kegan,...
General Hospital · 48d
Cleared Apr 17, 1984
MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT
K840918 · KLK
Biochem International, Inc.
Anesthesiology · 47d
Cleared Apr 17, 1984
DAYPAK SYS VII CATHETER CARE KIT
K840919 · KLK
Creative Care Systems, Inc.
Anesthesiology · 47d
Cleared Apr 17, 1984
ANGIOGRAPHY NEEDLE W/WO CONNECTION
K840923 · DYB
Dlp, Inc.
Cardiovascular · 46d
Cleared Apr 17, 1984
DESERET LONG TERM INDWELLING CATHETER
K840958 · LJS
Parke-Davis Co.
General Hospital · 42d
Cleared Apr 17, 1984
BATTERY POWERED PATIENT LIFT
K840997 · FSA
Invacare Corp.
General Hospital · 40d
Cleared Apr 17, 1984
HOLDER FOR MODELS AF-10,1025,1040,5
K841032 · KRI
American Bentley
Cardiovascular · 36d
Cleared Apr 17, 1984
PRESSURE MANOMETER
K841071 · DQX
Interventional Medical, Inc.
Cardiovascular · 36d
Cleared Apr 17, 1984
WILLIAM HARVEY H-4700 FILTER/CARDIO
K841079 · DTN
C.R. Bard, Inc.
Cardiovascular · 35d
Cleared Apr 17, 1984
DRESSING CHANGE TRAY
K841123 · FRG
Medcare Products
General Hospital · 33d
Cleared Apr 17, 1984
MINI PECG-MODIFICATION
K841148 · DPS
Intersect Systems, Inc.
Cardiovascular · 27d
Cleared Apr 17, 1984
MULTIPLE BIOCHEMICAL TEST
K841204 · JSE
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
NON-SELECTIVE & DIFFERENTIAL
K841206 · JSH
Smith River Biologicals
Microbiology · 36d
Cleared Apr 17, 1984
NON-SELECTIVE & NON-DIFFERENTIAL
K841207 · JSI
Smith River Biologicals
Microbiology · 36d