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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90121–90144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1998
LEKSELL STEREOTACTIC SYSTEM
K972324 · HAW
Elekta Instrument AB
Neurology · 252d
Cleared Mar 02, 1998
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
K973108 · CEK
Diagnostic Chemicals , Ltd.
Chemistry · 195d
Cleared Mar 02, 1998
COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN
K973357 · JDC
Zimmer, Inc.
Orthopedic · 175d
Cleared Mar 02, 1998
PORTABLE INTENSIVE CARE UNIT
K974034 · DRO
Medical Research Laboratories, Inc.
Cardiovascular · 130d
Cleared Mar 02, 1998
HYDROFERA SURGICAL SPEAR
K974313 · HOZ
Hydrofera, LLC
Ophthalmic · 105d
Cleared Mar 02, 1998
THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012
K974475 · LJT
Biocontrol Technology, Inc.
General Hospital · 96d
Cleared Mar 02, 1998
SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM
K974525 · KWQ
Synthes Spine
Orthopedic · 90d
Cleared Mar 02, 1998
COLPO CUP CVC-2000
K974563 · HDP
Clinical Innovations, Inc.
Obstetrics & Gynecology · 87d
Cleared Mar 02, 1998
ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT...
K974599 · LPL
Opti-Centre Laboratories
Ophthalmic · 83d
Cleared Mar 02, 1998
SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT...
K974724 · LYL
Lens Comfort, Inc.
Ophthalmic · 74d
Cleared Mar 02, 1998
SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71
K980032 · DKJ
Diagnostic Chemicals , Ltd.
Toxicology · 56d
Cleared Mar 02, 1998
EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE...
K980061 · MFD
Rocket Medical Plc
Obstetrics & Gynecology · 54d
Cleared Mar 02, 1998
DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE
K980093 · LYZ
Universal Gloves Corp.
General Hospital · 52d
Cleared Feb 27, 1998
FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
K971348 · CAO
Green Field Medical Sourcing, Inc.
Anesthesiology · 323d
Cleared Feb 27, 1998
MICROFUSE MEMBRANE INFUSION CATHETER
K971619 · KRA
E-Med Corp.
Cardiovascular · 302d
Cleared Feb 27, 1998
ULTRACON ULTRAFILTRATOR
K971710 · FJI
Quantic Biomedical, Inc.
Gastroenterology & Urology · 295d
Cleared Feb 27, 1998
NT2000
K972244 · GZJ
Bio-Medical Research, Ltd.
Neurology · 256d
Cleared Feb 27, 1998
S3 MAST PUMP
K972321 · DWB
Stoeckert Instrumente
Cardiovascular · 249d
Cleared Feb 27, 1998
FASTDAM
K972775 · EIE
Interdent, Inc.
Dental · 218d
Cleared Feb 27, 1998
FIRE STICK
K973197 · GEI
H.S. Intl. Co., Inc.
General & Plastic Surgery · 185d
Cleared Feb 27, 1998
KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
K973409 · KNT
Davis & Geck, Inc.
Gastroenterology & Urology · 171d
Cleared Feb 27, 1998
THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM
K973425 · MNH
Corin USA
Orthopedic · 170d
Cleared Feb 27, 1998
BIOSCREW ABSORBABLE INTERFERENCE SREW
K973758 · HWC
Linvatec Corp.
Orthopedic · 148d
Cleared Feb 27, 1998
KSEA ENDOTIP SYSTEM
K973909 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 136d