Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
38833–38856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 2014
LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM
K133525 · HRS
Changzhou Dean Medical Instrument Co,...
Orthopedic · 109d
Cleared Mar 04, 2014
LIGHTHOUSE URINARY CATHETER
K140099 · EZL
Seedings Life Science Ventures, LLC
Gastroenterology & Urology · 47d
Cleared Mar 04, 2014
SONIC WINDOW
K140126 · IYO
Analogic Corporation
Radiology · 47d
Cleared Mar 03, 2014
IPM WOUND GEL BIO
K123193 · FRO
Glycobiosciences, Inc.
General & Plastic Surgery · 508d
Cleared Mar 03, 2014
SFI-ANCHOR
K130618 · NHA
Cendres & Metaux SA
Dental · 361d
Cleared Mar 03, 2014
VISICLEAR SMOKE EVACUATION SYSTEM
K131402 · FYD
Buffalo Filter Co., Inc.
General Hospital · 292d
Cleared Mar 03, 2014
MOERAE VEIN PREPARATION KIT
K131659 · GBX
Moerae Matrix, Inc.
General & Plastic Surgery · 270d
Cleared Mar 03, 2014
SKINTELL
K132800 · NQQ
Agfa Healthcare N.V.
General & Plastic Surgery · 178d
Cleared Mar 03, 2014
NXSTAGE SYSTEM ONE WITH NXVIEW
K133547 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 104d
Cleared Mar 03, 2014
AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE...
K133668 · HRS
Shoulder Options, Inc.
Orthopedic · 94d
Cleared Mar 03, 2014
HEARTSCAN SOFTWARE
K133937 · LLZ
Morpheus Imaging, Inc.
Radiology · 70d
Cleared Feb 28, 2014
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
K130255 · PDJ
Abbott Laboratories
Chemistry · 392d
Cleared Feb 28, 2014
JINTRONIX REHABILITATION SYSTEM (JRS)
K130847 · LXJ
Jintronix, Inc.
Physical Medicine · 339d
Cleared Feb 28, 2014
LERADO, POWER WHEELCHAIR
K130982 · ITI
Lerado Global (Macao Commercial...
Physical Medicine · 325d
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