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
56449–56472 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 2008
COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE
K080677 · EIA
Kaltenbach & Voigt GmbH & Co.
Dental · 88d
Cleared Jun 06, 2008
UNI-KNEE 2.0
K080678 · HAW
Brainlab AG
Neurology · 88d
Cleared Jun 06, 2008
TR-USB TELEPHONIC STETHOSCOPE
K081032 · DQD
Rnk Products, Inc.
Cardiovascular · 56d
Cleared Jun 06, 2008
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2
K081065 · IYN
Toshiba America Medical Systems, In.C
Radiology · 52d
Cleared Jun 06, 2008
PREFERENCE PEDICLE SCREW SYSTEM
K081296 · MNH
Us Spine
Orthopedic · 30d
Cleared Jun 06, 2008
AVIATOR TRANSPORT INCUBATOR
K081399 · FPL
International Biomedical, Ltd.
General Hospital · 18d
Cleared Jun 06, 2008
PROVEN STEM EXTENDER
K081458 · JWH
Stelkast Company
Orthopedic · 14d
Cleared Jun 05, 2008
GRADIA FORTE
K080478 · EBF
GC America, Inc.
Dental · 104d
Cleared Jun 05, 2008
FINGER PULSE OXIMETER, MODEL 9560
K081285 · DQA
Nonin Medical, Inc.
Anesthesiology · 30d
Cleared Jun 05, 2008
MERCI RETRIEVER
K081305 · NRY
Concentric Medical, Inc.
Neurology · 28d
Cleared Jun 04, 2008
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION...
K071597 · LOJ
Dade Behring, Inc.
Immunology · 358d
Cleared Jun 04, 2008
STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM
K073109 · OVD
Surgicraft , Ltd.
Orthopedic · 215d
Cleared Jun 04, 2008
VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
K073155 · BZG
Vitalograph (Ireland) , Ltd.
Anesthesiology · 209d
Cleared Jun 04, 2008
MRI PATIENT POSITIONING DEVICES
K080072 · IYE
CIVCO Medical Instruments Co., Inc.
Radiology · 145d
Cleared Jun 04, 2008
DRF 4343
K080859 · JAA
Villa Sistemi Medicali S.P.A.
Radiology · 69d
Cleared Jun 04, 2008
DVX SPINE SYSTEM
K080876 · MNH
Bk Meditech, Co., Ltd.
Orthopedic · 65d
Cleared Jun 04, 2008
FEEL-FINE INSULIN PEN NEEDLE
K080904 · FMI
Feel Tech
General Hospital · 64d
Cleared Jun 04, 2008
21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)
K081055 · LLZ
Totoku Electric Co., Ltd.
Radiology · 51d
Cleared Jun 04, 2008
21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A)
K081056 · LLZ
Totoku Electric Co., Ltd.
Radiology · 51d
Cleared Jun 04, 2008
MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM
K081121 · IYO
Siemens Medical Solutions USA, Inc.,...
Radiology · 44d
Cleared Jun 04, 2008
FUJIFILM FCR VIEW, MODEL CR-VW674
K081308 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 26d
Cleared Jun 04, 2008
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
K081311 · LJT
C.R. Bard, Inc.
General Hospital · 26d
Cleared Jun 04, 2008
FOXCROSS PTA CATHETER
K081417 · LIT
Abbott Vascular, Inc.
Cardiovascular · 15d
Cleared Jun 04, 2008
NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE
K081426 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 14d