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

Filters: Cleared only ×
175,820 results
51001–51024 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 2010
TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE
K092366 · LGZ
Thermal Therapeutic Systems, Inc.
General Hospital · 211d
Cleared Mar 04, 2010
VERICORE ABUTMENT IN TITANIUM FOR IMPLANT SYSTEMS
K092857 · NHA
Whip-Mix Corp.
Dental · 169d
Cleared Mar 04, 2010
AUTOSTART BURETTE
K092905 · FPA
Analytica Pty, Ltd.
General Hospital · 164d
Cleared Mar 04, 2010
TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET
K093127 · MQP
Zimmer Trabecular Metal Technology
Orthopedic · 153d
Cleared Mar 04, 2010
AQUALASE CAPSULE WASH TIP
K093210 · HQC
Alcon Manufacturing, Ltd.
Ophthalmic · 142d
Cleared Mar 04, 2010
SINGLE-PATIENT USE DISPOSABLE SENSOR
K093306 · DQA
Nonin Medical, Inc.
Anesthesiology · 133d
Cleared Mar 04, 2010
SMART CAPNOLINE GUARDIAN
K093388 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 125d
Cleared Mar 04, 2010
RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)
K093508 · HGH
Womancare Global
Obstetrics & Gynecology · 112d
Cleared Mar 04, 2010
MICRO-TOUCH NITRILE
K093523 · LZA
Ansell Healthcare Products, LLC
General Hospital · 111d
Cleared Mar 04, 2010
EVOLUTION MP TOTAL KNEE SYSTEM
K093552 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 107d
Cleared Mar 04, 2010
RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR
K093576 · LYZ
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 106d
Cleared Mar 04, 2010
SYNGO.PLAZA
K093612 · LLZ
Siemens AG Medical Solutions
Radiology · 101d
Cleared Mar 04, 2010
SPI DENTAL IMPLANT, ELEMENT
K093615 · DZE
Thommen Medical AG
Dental · 101d
Cleared Mar 04, 2010
ELECSYS HCG STAT CALCHECK 5
K093700 · JJX
Roche Diagnostics Corp.
Chemistry · 93d
Cleared Mar 04, 2010
REPROCESSED ULTRASONIC COAGULATING SHEARS
K093702 · NLQ
Ascent Healthcare Solutions
General & Plastic Surgery · 93d
Cleared Mar 04, 2010
SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR
K093897 · MBI
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 76d
Cleared Mar 04, 2010
AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7
K100016 · FLL
Avita Corporation
General Hospital · 59d
Cleared Mar 04, 2010
PASS LP SPINAL SYSTEM
K100297 · MNI
Medicrea Technologies
Orthopedic · 30d
Cleared Mar 03, 2010
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
K090658 · KTT
Synthes (Usa)
Orthopedic · 356d
Cleared Mar 03, 2010
GS III SYSTEM
K091208 · DZE
Osstem Implant Co., Ltd.
Dental · 313d
Cleared Mar 03, 2010
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200
K092331 · KWA
Encore Medical, L.P.
Orthopedic · 211d
Cleared Mar 03, 2010
COLOR LCD MONITOR, MODEL RADIFORCE RS210
K092613 · LLZ
Eizo Nanao Corporation
Radiology · 189d
Cleared Mar 03, 2010
GRINDCARE
K092675 · HCC
Medotech A/S
Neurology · 183d
Cleared Mar 03, 2010
MGB DISPOSABLE RETRIEVAL BAG LAPBAG
K093194 · GCJ
Mgb Endoskopische Gerate GmbH (Berlin)
General & Plastic Surgery · 145d