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

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176,076 results
162841–162864 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1981
STERILE BASIN SETS
K813012 · LDQ
Medspec Corp.
General & Plastic Surgery · 10d
Cleared Nov 06, 1981
OXYTRON OXYGEN GENERATOR
K813018 · CAW
Elmore Technology Corp.
Anesthesiology · 10d
Cleared Nov 05, 1981
HERPES
K811021 · GQN
Immuno-Diagnostic Products, Inc.
Microbiology · 204d
Cleared Nov 05, 1981
AUTOMATED ELECTROCAUTERY SYSTEM
K812213 · KNS
University of Washington
Gastroenterology & Urology · 92d
Cleared Nov 05, 1981
ENGSTROM ERICA
K812642 · CBK
Lkb Instruments, Inc.
Anesthesiology · 50d
Cleared Nov 05, 1981
URICAR
K812700 · KNK
Hi Chem, Inc.
Chemistry · 43d
Cleared Nov 05, 1981
TECHNICATOR
K812702 · GEI
Cameron-Miller, Inc.
General & Plastic Surgery · 43d
Cleared Nov 05, 1981
DRAWER TEST
K812713 · FTY
Medmetric Corp.
General & Plastic Surgery · 41d
Cleared Nov 05, 1981
BODAI PATIENT COMMUNICATOR
K812720 · ILQ
Sontek Industries, Inc.
Physical Medicine · 41d
Cleared Nov 05, 1981
SAFE GUARD
K812722 · GEI
Concept, Inc.
General & Plastic Surgery · 38d
Cleared Nov 05, 1981
KERMATH THERAPY SIMULATOR
K812726 · KPQ
Kermath Mfg. Corp.
Radiology · 38d
Cleared Nov 05, 1981
GASTRIN 1-17 BY RADIOIMMUNOASSAY KIT
K812727 · CGC
Immuno Nuclear Corp.
Chemistry · 38d
Cleared Nov 05, 1981
MODEL 325C UNIPOLAR CARDIAC PULSE GEN.
K812832 · DXY
Cook Pacemaker Corp.
Cardiovascular · 27d
Cleared Nov 04, 1981
DIGITRON
K812721 · IZI
Siemens Corp.
Radiology · 37d
Cleared Nov 02, 1981
FE-CULT PLUS
K811752 · KHE
Gamma Biologicals, Inc.
Toxicology · 133d
Cleared Nov 02, 1981
KENZ-GELECT
K812263 · GYB
Suzuken Co., Ltd.
Neurology · 81d
Cleared Nov 02, 1981
SPHYGMOMANOMETER
K812409 · DXN
Somatronix Research Corp.
Cardiovascular · 73d
Cleared Nov 02, 1981
450/800 DRILL
K812436 · HBC
Black & Decker(Tm)
Neurology · 68d
Cleared Nov 02, 1981
150 DRIVER REAMER
K812437 · GEY
Black & Decker(Tm)
General & Plastic Surgery · 68d
Cleared Nov 02, 1981
SAGITTAL SAW
K812438 · GEY
Black & Decker(Tm)
General & Plastic Surgery · 68d
Cleared Nov 02, 1981
DUAL MPC CHARGER
K812439
Black & Decker(Tm)
Orthopedic · 68d
Cleared Nov 02, 1981
POWER PACK
K812440
Black & Decker(Tm)
Orthopedic · 68d
Cleared Nov 02, 1981
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C
K812556 · JJY
American Dade
Immunology · 55d
Cleared Nov 02, 1981
GAUZE SPONGES
K812572 · EFQ
Worldwide Surgical Gauze
General & Plastic Surgery · 54d