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
71305–71328 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2003
DEPUY ACE VERSANAIL TIBIAL NAIL
K032097 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 31d
Cleared Aug 08, 2003
STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
K032117 · DZI
Stryker Instruments
Dental · 30d
Cleared Aug 08, 2003
DATACAPTOR
K032142 · MWI
Capsule Technologie
Cardiovascular · 25d
Cleared Aug 08, 2003
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
K032162 · LGD
Beckman Coulter, Inc.
Microbiology · 24d
Cleared Aug 08, 2003
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
K032197 · MAI
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Aug 08, 2003
PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
K032206 · FGE
Ev3, Inc.
Gastroenterology & Urology · 21d
Cleared Aug 08, 2003
VKS/TC-PLUS REVISION KNEE
K032215 · JWH
Plus Orthopedics
Orthopedic · 18d
Cleared Aug 08, 2003
BIORCI SCREW
K032224 · HWC
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Aug 08, 2003
GAMMA 3 NAIL SYSTEM
K032244 · HSB
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Aug 08, 2003
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
K032264 · HSD
Howmedica Osteonics Corp.
Orthopedic · 16d
Cleared Aug 08, 2003
CARDIOVATIONS PORTABLE VIDEO SYSTEM
K032339 · GCJ
Ethicon, Inc.
General & Plastic Surgery · 10d
Cleared Aug 07, 2003
LAPMAN LAPAROSCOPE MANIPULATOR SYSTEM AND ACCESSORIES, MODEL 900-001
K023735 · GCJ
Medsys, S.A.
General & Plastic Surgery · 273d
Cleared Aug 07, 2003
AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR)
K030316 · DRX
Inovise Medical, Inc.
Cardiovascular · 189d
Cleared Aug 07, 2003
SWIFT 2.0, MODEL 132.001
K031158 · JAQ
Nucletron Corp.
Radiology · 118d
Cleared Aug 07, 2003
OTP 1.2
K031349 · MUJ
Nucletron Corp.
Radiology · 100d
Cleared Aug 07, 2003
KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II
K031432 · FRN
Hk Surgical, Inc.
General Hospital · 93d
Cleared Aug 07, 2003
HEATER COOLER UNIT, MODEL HCU 30
K031544 · DWC
Jostra AB
Cardiovascular · 83d
Cleared Aug 07, 2003
CORRESTORE PATCH SYSTEM
K031586 · DXZ
Somanetics Corp.
Cardiovascular · 78d
Cleared Aug 07, 2003
BIFURCATED ALLERGY SKIN TESTING NEEDLE
K031630 · SCL
Precision Medical Products, Inc.
General Hospital · 72d
Cleared Aug 07, 2003
SPINAL CONCEPTS, INC. INFIX SYSTEM
K031672 · MQP
Spinal Concepts, Inc.
Orthopedic · 69d
Cleared Aug 07, 2003
PRACTICEBUILDER 1-2-3
K031778 · LLZ
Erad Imagemedical Corp.
Radiology · 58d
Cleared Aug 07, 2003
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK,...
K031924 · JIT
Ortho-Clinical Diagnostics
Chemistry · 45d
Cleared Aug 07, 2003
ECHELON MICRO CATHETER, MODEL 105-5091
K031992 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 41d
Cleared Aug 07, 2003
N LATEX IGM
K032014 · CFN
Dade Behring, Inc.
Immunology · 38d