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
84865–84888 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1999
NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM
K990324 · HRX
Nuvasive, Inc.
Orthopedic · 245d
Cleared Oct 05, 1999
DYONICS VARICOSE VEIN ABLATION BLADE
K990723 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 214d
Cleared Oct 05, 1999
V.T.S., INC. (V.T.-3)
K992442 · LKY
Vts, Inc.
Gastroenterology & Urology · 75d
Cleared Oct 05, 1999
CAUTERY CLAMP AND BATTERY PACK POWER SUPPLY
K992460 · GEI
Starion Instruments
General & Plastic Surgery · 74d
Cleared Oct 05, 1999
MICROGRASP MONOPOLAR COAGULATOR, MODEL NOS 90001-90010
K992714 · GEI
Hysterx, Inc.
General & Plastic Surgery · 54d
Cleared Oct 05, 1999
NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES
K992782 · HRX
Nuvasive, Inc.
Orthopedic · 47d
Cleared Oct 05, 1999
MINI-PORT
K992904 · GBW
Taut, Inc.
General & Plastic Surgery · 36d
Cleared Oct 05, 1999
INTRADUCER
K992907 · GBW
Taut, Inc.
General & Plastic Surgery · 36d
Cleared Oct 05, 1999
DEXIDE BIPOLAR FORCEPS II** DEVICE
K993055 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 22d
Cleared Oct 05, 1999
MBA
K993057 · DTL
Merit Medical Systems, Inc.
Cardiovascular · 22d
Cleared Oct 05, 1999
ALCYON 300I (WITH ISE MODULE) ANALYZER
K993083 · CEM
Abbott Laboratories
Chemistry · 20d
Cleared Oct 05, 1999
ASCENT KNEE SYSTEM
K993111 · JWH
Biomet Manufacturing, Inc.
Orthopedic · 18d
Cleared Oct 04, 1999
CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078
K991531 · DRF
Cordis Webster, Inc.
Cardiovascular · 154d
Cleared Oct 04, 1999
CARDIOQUANT TROPONIN I TEST
K992127 · MMI
Spectral Diagnostics, Inc.
Chemistry · 103d
Cleared Oct 04, 1999
INDIGO PROSTATE SEEDING NEEDLE CARTRIDGE SYSTEM
K992262 · KXK
Indigo Medical, Inc.
Radiology · 90d
Cleared Oct 04, 1999
OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR
K992466 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 73d
Cleared Oct 04, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
K993068 · JHX
Ortho-Clinical Diagnostics
Chemistry · 21d
Cleared Oct 04, 1999
GENZYME DIRECT AMYLASE VERIFIER
K993132 · JIT
Genzyme Corp.
Chemistry · 14d
Cleared Oct 01, 1999
POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
K990276 · KRJ
Porous Media Corp.
Cardiovascular · 246d
Cleared Oct 01, 1999
T-ANASTAFLO
K990396 · DWF
Edwards Lifesciences Research Medical
Cardiovascular · 234d
Cleared Oct 01, 1999
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
K991965 · LYL
Purilens, Inc.
Ophthalmic · 113d
Cleared Oct 01, 1999
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
K992271 · LYZ
Shanghai Cosmos Corp.
General Hospital · 86d
Cleared Oct 01, 1999
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992272 · LYZ
Shanghai Cosmos Corp.
General Hospital · 86d
Cleared Oct 01, 1999
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K992276 · MNI
Sulzer Spine-Tech
Orthopedic · 86d