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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
59113–59136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 19, 2007
VIEW MD OFFICE SYSTEM, MODEL 41066.5540
K071292 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 72d
Cleared Jul 19, 2007
EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS
K071676 · KWZ
Exactech, Inc.
Orthopedic · 30d
Cleared Jul 19, 2007
MODIFICATION TO DISPOSABLE INFUSION PUMP KIT
K071735 · MEB
Symbios Medical Products, LLC
General Hospital · 23d
Cleared Jul 19, 2007
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE
K071745 · GXI
Baylis Medical Co., Inc.
Neurology · 22d
Cleared Jul 18, 2007
VR LUNG ELECTROSONOGRAPH
K061495 · OCR
Deep Breeze , Ltd.
Anesthesiology · 413d
Cleared Jul 18, 2007
DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM
K070346 · LON
Dade Behring, Inc.
Microbiology · 162d
Cleared Jul 18, 2007
SMARTEP, MODEL M010000
K070608 · GWJ
Intelligent Hearing Systems
Neurology · 135d
Cleared Jul 18, 2007
WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603
K071163 · BZD
Weinmann Gerate Fur Medizin GmbH +...
Anesthesiology · 83d
Cleared Jul 18, 2007
GAMMAMEDPLUS IX SERIES HDR AFTERLOADER
K071381 · JAQ
Varian Medical Systems
Radiology · 62d
Cleared Jul 18, 2007
MEDLINE LATEX FOLEY CATHETER
K071423 · EZL
Medline Industries, Inc.
Gastroenterology & Urology · 57d
Cleared Jul 18, 2007
PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
K071550 · KXK
Cp Medical
Radiology · 42d
Cleared Jul 18, 2007
SOMNOSCREEN EEG10-20
K071556 · MNR
Somnomedics GmbH
Anesthesiology · 41d
Cleared Jul 18, 2007
SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552
K071665 · DQY
Biotronik, Inc.
Cardiovascular · 30d
Cleared Jul 18, 2007
ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032
K071673 · IYE
Onc Solutions, Inc.
Radiology · 29d
Cleared Jul 18, 2007
ACUMED CONGRUENT BONE PLATE SYSTEM
K071715 · HRS
Acumed, LLC
Orthopedic · 26d
Cleared Jul 18, 2007
MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,
K071882 · MOS
Shanghai Chenguang Medical...
Radiology · 9d
Cleared Jul 17, 2007
XTAC
K061934 · FTL
Osteogenics, Inc.
General & Plastic Surgery · 375d
Cleared Jul 17, 2007
MEDICOM SELF-SEALING STERILIZATION POUCH
K070428 · KCT
A.R. Medicom, Inc.
General Hospital · 154d
Cleared Jul 17, 2007
DR BROWN'S NATURAL FLOW DOUBLE ELECTRIC BREAST PUMP, MODEL# 1400
K070435 · HGX
Whittlestone, Inc.
Obstetrics & Gynecology · 152d
Cleared Jul 17, 2007
VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4
K070461 · JOJ
STERIS Corporation
General Hospital · 151d
Cleared Jul 17, 2007
NON-ABSORBABLE SILK SUTURE
K071111 · GAP
Arrow Intl., Inc.
General & Plastic Surgery · 88d
Cleared Jul 17, 2007
OHMEDA MEDICAL GIRAFFE OMNIBED
K071175 · FMZ
Ge Healthcare
General Hospital · 81d
Cleared Jul 17, 2007
HERMES BOND 3
K071260 · KLE
3M Espe AG Dental Products
Dental · 71d
Cleared Jul 16, 2007
SATURN 9000
K063710 · MQB
New Medical Co., Ltd.
Radiology · 214d