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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
140689–140712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1987
CLED AGAR
K871095 · JSH
bioMerieux, Inc.
Microbiology · 16d
Cleared Apr 03, 1987
CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES
K871096 · JSE
bioMerieux, Inc.
Microbiology · 16d
Cleared Apr 03, 1987
CHOCOLATE MUELLER HINTON AGAR
K871097 · JTZ
bioMerieux, Inc.
Microbiology · 16d
Cleared Apr 03, 1987
TRYPTIC SOY AGAR
K871098 · JSG
bioMerieux, Inc.
Microbiology · 16d
Cleared Apr 03, 1987
TB QUICK STAIN(TM) KIT
K871117 · ICJ
Bd Becton Dickinson Vacutainer...
Pathology · 15d
Cleared Apr 03, 1987
LUMIFOR(TM) COMPOSITE
K871165 · EBF
Columbus Dental Mfg. Co.
Dental · 10d
Cleared Apr 03, 1987
(DMF/F-12) HYBRI-MAX(TM) W/L-GLUTAMINE
K871191 · KIT
Sigma Chemical Co.
Pathology · 10d
Cleared Apr 03, 1987
ANABAG
K871238 · KZJ
Scott Laboratories, Inc.
Microbiology · 7d
Cleared Apr 01, 1987
MODEL 10200 PREMATURE INFANT INCUBATOR
K862921 · FMT
Rotem Industries C/O Medsys, Inc.
General Hospital · 243d
Cleared Apr 01, 1987
TENS DEVICE FOR RELIEF OF CHRONIC PAIN
K864114 · GZJ
Futuremed Div. of Future Impex Corp.
Neurology · 162d
Cleared Apr 01, 1987
VIGGO EXACTA PRESSURE MONITORING KIT
K864900 · FMG
Ohmeda Medical
General Hospital · 107d
Cleared Apr 01, 1987
THE LAHR BALLOON
K870019 · FCE
Plasco, Inc.
Gastroenterology & Urology · 89d
Cleared Apr 01, 1987
PERSONAL PUNCH
K870136 · EXB
Arnold Technologies
Gastroenterology & Urology · 78d
Cleared Apr 01, 1987
DYNEX DISPOSABLE SELF-ADHERING ELECTRODE W/TENS
K870160 · GXY
La Jolla Technology, Inc.
Neurology · 78d
Cleared Apr 01, 1987
EMPI LOGIX MODEL 712 NMS, TENS
K870168 · GZJ
Empi
Neurology · 77d
Cleared Apr 01, 1987
IQ TSH IMMUNOASSAY
K870244 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 70d
Cleared Apr 01, 1987
AUTOPAK TSH MONOCLONAL IRMA KIT
K870245 · JLW
Micromedic Systems
Chemistry · 70d
Cleared Apr 01, 1987
VIGGO EXACTA PRESSURE MONITORING SYSTEM
K870261 · FMG
Ohmeda Medical
General Hospital · 107d
Cleared Apr 01, 1987
PREFILLED RESPIRATORY THERAPY VIALS
K870332 · CCQ
Automatic Liquid Packaging, Inc.
Anesthesiology · 63d
Cleared Apr 01, 1987
(URETEROSCOPIC) STRICTURE SCAPEL OR KNIFE
K870355 · OCZ
Cook Urological, Inc.
Gastroenterology & Urology · 62d
Cleared Apr 01, 1987
DIGOXIN (FPIA) CALIBRATOR KIT
K870389 · DLJ
Windsor Laboratories, Inc.
Toxicology · 61d
Cleared Apr 01, 1987
PHENOBARBITAL (FPIA) CALIBRATOR KIT
K870390 · DLJ
Windsor Laboratories, Inc.
Toxicology · 61d
Cleared Apr 01, 1987
NORTA (TM) UROBAG
K870504 · KNX
Beiersdorf, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 01, 1987
PHILIPS MODEL SL75-10 LINEAR ACCELERATOR
K870525 · IYE
Industrial Accelerator Co.
Radiology · 54d