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
38041–38064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 2014
OP300
K133544 · OAS
Palodex Group OY
Radiology · 128d
Cleared Mar 26, 2014
CORGRIP
K133599 · KNT
Corpak Medsystems
Gastroenterology & Urology · 121d
Cleared Mar 26, 2014
ENCORE SYSTEM
K133680 · ORY
Siesta Medical, Inc.
Dental · 114d
Cleared Mar 26, 2014
EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
K133775 · FRO
Exciton Technologies, Inc.
General & Plastic Surgery · 104d
Cleared Mar 26, 2014
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX...
K133807 · FLD
Gambro Renal Products, Inc.
Gastroenterology & Urology · 100d
Cleared Mar 26, 2014
AMIPLIVUE HSV 1&2 ASSAY
K140029 · OQO
Quidel Corporation
Microbiology · 79d
Cleared Mar 26, 2014
COLLAGEN TENDON SHEET-DDI (CTS-DDI)
K140300 · OWY
Rotation Medical, Inc.
Orthopedic · 48d
Cleared Mar 26, 2014
MONOTEX
K140415 · NBY
Riverpoint Medical
General & Plastic Surgery · 36d
Cleared Mar 26, 2014
PEREGRINE SYSTEM INFUSION CATHETER
K140637 · KRA
Ablative Solutions, Inc.
Cardiovascular · 14d
Cleared Mar 25, 2014
NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
K131703 · CHL
Nova Biomedical Corporation
Chemistry · 287d
Cleared Mar 25, 2014
HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
K132017 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 267d
Cleared Mar 25, 2014
SOLACE SOUND GENERATORS
K132965 · KLW
Amplisound Hearing Products & Services
Ear, Nose, Throat · 186d
Cleared Mar 25, 2014
ASIR-V
K133640 · JAK
Ge Medical Systems, LLC
Radiology · 118d
Cleared Mar 25, 2014
NIO COLOR 2MP
K133663 · LLZ
Barco N.V.
Radiology · 116d
Cleared Mar 25, 2014
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL...
K133673 · OZZ
Meridian Bioscience, Inc.
Microbiology · 116d
Cleared Mar 25, 2014
ASPIRE CRISTALLE
K133972 · MUE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 89d
Cleared Mar 25, 2014
CAAS WORKSTATION
K133993 · IZI
Pie Medical Imaging
Radiology · 89d
Cleared Mar 25, 2014
SILEX SACROILIAC JOINT FUSION SYSTEM
K140079 · OUR
X-Spine Systems, Inc.
Orthopedic · 71d
Cleared Mar 25, 2014
SAFETY BIOPSY NEEDLE SYSTEM
K140137 · FCG
Pfm Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Mar 25, 2014
RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
K140393 · JJY
Randox Laboratories Limited
Chemistry · 39d
Cleared Mar 25, 2014
CD HORIZON SPINAL SYSTEM
K140449 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Mar 25, 2014
VEGA KNEE SYSTEM
K140452 · JWH
Aesculap Implant Systems
Orthopedic · 29d
Cleared Mar 25, 2014
NAUTILUS SPINAL SYSTEM
K140457 · NKB
Life Spine, Inc.
Orthopedic · 29d
Cleared Mar 24, 2014
RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW
K130550 · PHX
Encore Medical, L.P.
Orthopedic · 385d