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
82729–82752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2000
DYONICS ELECTROBLADE
K994365 · GEI
Smith & Nephew, Inc.
General & Plastic Surgery · 77d
Cleared Mar 10, 2000
SPIRAL RADIUS RODDING SYSTEM
K000009 · KWQ
United States Surgical, A Division of...
Orthopedic · 67d
Cleared Mar 10, 2000
BROTHERS POWDER-FREE VINYL EXAMINATION GLOVES
K000058 · LYZ
Kaohsiung Brothers Products Corp.
General Hospital · 60d
Cleared Mar 10, 2000
DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT
K000091 · JWH
Howmedica Osteonics Corp.
Orthopedic · 57d
Cleared Mar 10, 2000
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF...
K000165 · LYY
Ansell Perry
General Hospital · 51d
Cleared Mar 10, 2000
MODIFICATION TO SYNTHES USS
K000450 · MNI
Synthes Spine
Orthopedic · 28d
Cleared Mar 10, 2000
MODIFICATION TO CD SPINAL SYSTEM
K000453 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Mar 10, 2000
MODIFICATION TO CD SPINAL SYSTEM
K000476 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Mar 10, 2000
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
K000575 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 17d
Cleared Mar 10, 2000
ROD TO ROD CROSS BRACES
K000634 · KWQ
Corin USA
Orthopedic · 14d
Cleared Mar 10, 2000
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992821 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 203d
Cleared Mar 10, 2000
MAGELLAN TIBIAL INTRAMEDULLARY NAIL
K992850 · HSB
Orthomatrix, Inc.
Orthopedic · 199d
Cleared Mar 10, 2000
MAGELLAN HUMERAL INTRAMEDULLARY NAIL
K992856 · HSB
Orthomatrix, Inc.
Orthopedic · 199d
Cleared Mar 10, 2000
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
K993259 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 163d
Cleared Mar 10, 2000
NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE,...
K993805 · LZA
Best Manufacturing Company
General Hospital · 122d
Cleared Mar 10, 2000
ZMR HIP SYSTEM-POROUS REVISION
K994286 · LPH
Zimmer, Inc.
Orthopedic · 81d
Cleared Mar 10, 2000
NONLINEAR TAPER LAG SCREW
K994382 · HWC
Theken Surgical
Orthopedic · 73d
Cleared Mar 10, 2000
AEQUALIS SHOULDER FRACTURE SYSTEM
K994392 · KWS
Tornier
Orthopedic · 73d
Cleared Mar 09, 2000
BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
K000544 · HJX
Labtician Ophthalmics, Inc.
Ophthalmic · 20d
Cleared Mar 09, 2000
MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO...
K000566 · LTJ
Ortho-Clinical Diagnostics, Inc.
Immunology · 16d
Cleared Mar 09, 2000
ULTRASOUND SCANNER TYPE 2102
K000567 · IYO
B & K Medical A/S
Radiology · 16d
Cleared Mar 09, 2000
EMBRYON GIFT TRANSFER CATHETERS/SETS
K000656 · MQF
Rocket Medical Plc
Obstetrics & Gynecology · 10d
Cleared Mar 09, 2000
BRACHYVISION 6.0
K992762 · MUJ
Varian Assoc., Inc.
Radiology · 205d
Cleared Mar 09, 2000
PEGASYS ULTRA
K993946 · LLZ
Adac Laboratories
Radiology · 111d