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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
38257–38280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2014
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
K131334 · MXJ
Gold Standard Diagnostics
Microbiology · 295d
Cleared Feb 28, 2014
SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
K131548 · HSB
Synthes USA Products, LLC
Orthopedic · 274d
Cleared Feb 28, 2014
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
K131605 · LFZ
Roche Diagnostics
Microbiology · 270d
Cleared Feb 28, 2014
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
K131727 · LFR
Ceragem Medisys, Inc.
Chemistry · 261d
Cleared Feb 28, 2014
HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
K131777 · IWB
Hyper Technology, Inc.
Radiology · 256d
Cleared Feb 28, 2014
SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM
K131896 · LNH
Suzhou Anke Medical System Co., Ltd.
Radiology · 248d
Cleared Feb 28, 2014
BIOMARC FIDUCIAL MARKER
K132064 · IYE
Carbon Medical Technologies, Inc.
Radiology · 240d
Cleared Feb 28, 2014
THE BITE GUARD
K132469 · OBR
International Profit Builders, Inc.
Dental · 205d
Cleared Feb 28, 2014
COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE
K132580 · GAM
Ethicon, Inc.
General & Plastic Surgery · 196d
Cleared Feb 28, 2014
ADVANCED VIEWER
K132763 · LLZ
Brainlab AG
Radiology · 177d
Cleared Feb 28, 2014
GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
K132810 · LIT
Boston Scientific Corp
Cardiovascular · 172d
Cleared Feb 28, 2014
OXICARE FINGERTIP PULSE OXIMETER
K133090 · DQA
Delbio Incorporation
Anesthesiology · 151d
Cleared Feb 28, 2014
FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS
K133119 · JOW
Arjohuntleigh Polska SP Z.O.O.
Cardiovascular · 151d
Cleared Feb 28, 2014
ND: YAG LASER SYSTEM
K133158 · GEX
Beijing Toplaser Technology Co., Ltd.
General & Plastic Surgery · 134d
Cleared Feb 28, 2014
FIXOS SCREW SYSTEM
K133451 · HWC
Stryker Trauma AG
Orthopedic · 108d
Cleared Feb 28, 2014
THE DOME S6C
K133609 · LLZ
Nds Surgical Imaging
Radiology · 95d
Cleared Feb 28, 2014
SCENIUM
K133654 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Feb 28, 2014
ICONIX ALL SUTURE ANCHORS
K133671 · MBI
Stryker Corp.
Orthopedic · 91d
Cleared Feb 28, 2014
PRESTO BREAST BIOPSY DEVICE
K133702 · KNW
Sontina Medical, LLC
Gastroenterology & Urology · 87d
Cleared Feb 28, 2014
CHARLOTTE CLAW PLATE SYSTEM
K133715 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Feb 28, 2014
TENSYN BAND
K133858 · HTN
Dallen Medical, Inc.
Orthopedic · 71d
Cleared Feb 28, 2014
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133999 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 63d
Cleared Feb 28, 2014
MONODERM SURGICAL SUTURE
K140227 · GAM
Surgical Specialties Corp
General & Plastic Surgery · 29d
Cleared Feb 28, 2014
OSTEOMED EXTREMIFUSE SYSTEM
K140283 · HWC
Osteomed
Orthopedic · 24d