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
42841–42864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2012
ARTISAN EXTEND CONTROL CATHETER
K122275 · DRA
Hansen Medical
Cardiovascular · 30d
Cleared Aug 29, 2012
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
K122276 · FZP
AtriCure, Inc.
General & Plastic Surgery · 30d
Cleared Aug 29, 2012
PADNET 2.0
K122281 · JOM
Biomedix, Inc.
Cardiovascular · 30d
Cleared Aug 29, 2012
AZUR DETACHABLE 35
K122316 · KRD
MicroVention, Inc.
Cardiovascular · 28d
Cleared Aug 29, 2012
TETRIS II
K122317 · MAX
Signus Medizintechnik GmbH
Orthopedic · 28d
Cleared Aug 29, 2012
INTELLIVUE PATIENT MONITOR
K122439 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 19d
Cleared Aug 28, 2012
AIXPLORER
K112255 · IYN
Supersonic Imagine
Radiology · 389d
Cleared Aug 28, 2012
PMMA CAD/CAM DISC
K112967 · EBG
Polident D.O.O., Dental Products...
Dental · 328d
Cleared Aug 28, 2012
XIA 3 SPINAL SYSTEM
K113666 · NKB
Stryker Spine
Orthopedic · 259d
Cleared Aug 28, 2012
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY...
K120246 · MUE
Carestream Health, Inc.
Radiology · 214d
Cleared Aug 28, 2012
FDR GO FLEX
K120629 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 180d
Cleared Aug 28, 2012
CATALYS PRECISION LASER SYSTEM
K121091 · OOE
Optimedica Corporation
Ophthalmic · 140d
Cleared Aug 28, 2012
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK
K121251 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 125d
Cleared Aug 28, 2012
LARYNGEAL ELECTRODE
K121257 · ETN
Technomed Europe
Ear, Nose, Throat · 124d
Cleared Aug 28, 2012
PAX-UNI3D, PHT-7500
K121400 · OAS
VATECH Co., Ltd.
Radiology · 110d
Cleared Aug 28, 2012
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
K121482 · HRX
Theken Spine, LLC
Orthopedic · 102d
Cleared Aug 28, 2012
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER
K122027 · CAZ
Arrow International, Inc.
Anesthesiology · 48d
Cleared Aug 28, 2012
TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE
K122249 · FMI
Terumo (Philippines) Corporation
General Hospital · 32d
Cleared Aug 28, 2012
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
K122296 · LZO
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Aug 28, 2012
ENLUXTRA HUMIFIBER WOUND DRESSING
K122297 · FRO
Basf Venture Capital America, Inc.
General & Plastic Surgery · 28d
Cleared Aug 28, 2012
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION...
K122323 · CJO
Siemens Healthcare Diagnostics
Chemistry · 27d
Cleared Aug 28, 2012
VITEK 2 STRPTOCOCCUS CEFTRIAXONE
K122359 · LON
bioMerieux, Inc.
Microbiology · 25d
Cleared Aug 28, 2012
ULTHERA SYSTEM
K122528 · OHV
Ulthera, Inc.
General & Plastic Surgery · 8d
Cleared Aug 27, 2012
BAROSTAT SOFTWARE OPTION
K120997 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 147d