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
70777–70800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 08, 2003
HBS HEADLESS BONE SCREW
K030302 · HWC
Schoening & Assoc., Inc.
Orthopedic · 191d
Cleared Aug 08, 2003
OPUS SPINAL SYSTEM
K030369 · NKB
Howmedica Osteonics Corp.
Orthopedic · 185d
Cleared Aug 08, 2003
LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE
K030529 · LZA
Jda (Tianjin) Plastic Rubber Co., Ltd.
General Hospital · 170d
Cleared Aug 08, 2003
IMMUNICON CELLSAVE PRESERVATIVE TUBE
K030596 · JKA
Immunicon Corp.
Chemistry · 164d
Cleared Aug 08, 2003
SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE
K031428 · LXT
Synthes (Usa)
Orthopedic · 94d
Cleared Aug 08, 2003
RANDOX LIQUID PROTEIN CALIBRATOR
K031608 · JIX
Randox Laboratories, Ltd.
Chemistry · 78d
Cleared Aug 08, 2003
SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED)
K031654 · GXR
Synthes (Usa)
Neurology · 72d
Cleared Aug 08, 2003
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K031702 · KWQ
Howmedica Osteonics
Orthopedic · 67d
Cleared Aug 08, 2003
OMNIFIT HFX HIP STEM SERIES
K031744 · JDI
Howmedica Osteonics Corp.
Orthopedic · 64d
Cleared Aug 08, 2003
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
K031789 · ODG
Pentax Precision Instrument Corp.
Radiology · 59d
Cleared Aug 08, 2003
HANDMASTER
K031900 · GZI
Ness-Neuromuscular Electrical...
Neurology · 50d
Cleared Aug 08, 2003
EMBRYON ULTRASOUND NEEDLE GUIDE
K032015 · MQE
Rocket Medical Plc
Radiology · 39d
Cleared Aug 08, 2003
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
K032017 · GGN
Bio-Rad
Hematology · 39d
Cleared Aug 08, 2003
PERIVAC KIT
K032050 · DQX
Boston Scientific Corp
Cardiovascular · 37d
Cleared Aug 08, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K032095 · JDK
Interpore Cross Intl.
Orthopedic · 31d
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