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
96193–96216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 1996
ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM
K963217 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 47d
Cleared Oct 01, 1996
COTREL-DUBOUSSET (CD) SPINAL
K955807 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 284d
Cleared Oct 01, 1996
MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT...
K955846 · FLL
Y
General Hospital · 280d
Cleared Oct 01, 1996
PRESS-FIT FLARED SHELL
K960633 · LWJ
Encore Orthopedics, Inc.
Orthopedic · 230d
Cleared Oct 01, 1996
B. BRAUN GUIDEWIRES
K961107 · DQX
B.Braun Medical, Inc.
Cardiovascular · 195d
Cleared Oct 01, 1996
PRECISION UV (VASURFILCON A)
K961299 · LPL
Pilkington Barnes-Hind, Ltd.
Ophthalmic · 180d
Cleared Oct 01, 1996
AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM
K961304 · JDI
Exactech, Inc.
Orthopedic · 180d
Cleared Oct 01, 1996
FLEXLENS
K961943 · LPL
Flexlens, Inc.
Ophthalmic · 134d
Cleared Oct 01, 1996
FLEXLENS(METHAFILCON A)
K962000 · LPL
Flexlens, Inc.
Ophthalmic · 132d
Cleared Oct 01, 1996
INTRA-ORAL THERMOPLASTIC SHIELD
K962622 · KPY
Medtec, Inc.
Radiology · 88d
Cleared Oct 01, 1996
PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH...
K962695 · LJT
Sims Deltec, Inc.
General Hospital · 82d
Cleared Oct 01, 1996
MLI MODULAR STAPLE
K962705 · JDR
Medicinelodge, Inc.
Orthopedic · 81d
Cleared Oct 01, 1996
EVIDENCE PREGNANCY TEST
K962721 · LCX
Saliva Diagnostic Systems
Chemistry · 78d
Cleared Oct 01, 1996
MITEK MICRO ANCHOR
K962793 · JDR
Mitek Products
Orthopedic · 76d
Cleared Oct 01, 1996
ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER
K962804 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 75d
Cleared Oct 01, 1996
SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER
K962823 · HWC
Synthes (Usa)
Orthopedic · 74d
Cleared Oct 01, 1996
DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)
K962923 · LPH
Depuy, Inc.
Orthopedic · 64d
Cleared Oct 01, 1996
RURASOFT 2 FRESHLOOK COLORS
K962957 · LPL
Wesley Jessen Corp.
Ophthalmic · 63d
Cleared Oct 01, 1996
TIBIAL INSERT
K963028 · JWH
Encore Orthopedics, Inc.
Orthopedic · 57d
Cleared Oct 01, 1996
MANUAL PHENYLALANINE TEST
K963040 · JNB
Bio-Rad
Chemistry · 57d
Cleared Oct 01, 1996
INFANT WARMER SYSTEM
K963058 · FMT
Ohmeda Medical
General Hospital · 56d
Cleared Oct 01, 1996
TBD
K963077 · HSB
Acu Med, Inc.
Orthopedic · 54d
Cleared Oct 01, 1996
INTERMOORE FRACTURE HIP STEM (MODIFY)
K963155 · LWJ
Intermedics Orthopedics
Orthopedic · 57d
Cleared Oct 01, 1996
HEELBO BLAZER SLEEVED JACKET
K963243 · FMQ
Heelbo, Inc.
General Hospital · 43d