FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90625–90648 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1998
SPECTRUM DESIGNS PROFILE MALAR IMPLANT
K980139 · LZK
Spectrum Designs, Inc.
General & Plastic Surgery · 47d
Cleared Mar 03, 1998
SPECTRUM DESIGNS MEDIAL MALAR IMPLANT
K980140 · LZK
Spectrum Designs, Inc.
General & Plastic Surgery · 47d
Cleared Mar 03, 1998
SPECTRUM DESIGNS PROJECTION MALAR IMPLANT
K980141 · LZK
Spectrum Designs, Inc.
General & Plastic Surgery · 47d
Cleared Mar 03, 1998
QUICKPAC II ONE STEP BARBITURATE TEST
K980349 · DIS
Syntron Bioresearch, Inc.
Toxicology · 34d
Cleared Mar 03, 1998
PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL...
K980381 · LHI
Carmel Pharma Ab.
General Hospital · 29d
Cleared Mar 03, 1998
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER...
K980414 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 28d
Cleared Mar 03, 1998
CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
K980528 · MMI
Chiron Diagnostics Corp.
Chemistry · 20d
Cleared Mar 02, 1998
WORLDS BEST BRAND NON-LUBRICATED, WORLDS BEST BRAND LUBRICATED
K971028 · HIS
Worlds-Best Gummivarefabrik A/S
Obstetrics & Gynecology · 347d
Cleared Mar 02, 1998
MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
K971759 · BTR
Green Field Medical Sourcing, Inc.
Anesthesiology · 294d
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