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
74833–74856 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2002
ACUTEVENTILATOR
K012271 · BTM
Impoex International, Ltd.
Anesthesiology · 442d
Cleared Oct 04, 2002
VANGUARD REPROCESSED PULSE OXIMETER SENSORS
K012344 · NLF
Vanguard Medical Concepts, Inc.
Anesthesiology · 437d
Cleared Oct 04, 2002
CONTREET-H ANTIMICROBIAL HYDROCOLLOID DRESSING, MODELS 9610 (4 X 4 (10 CM X...
K013525 · MGQ
Coloplast Corp.
General & Plastic Surgery · 346d
Cleared Oct 04, 2002
CANDELA SMOOTHBEAM LASER SYSTEM
K014128 · GEX
Candela Corp.
General & Plastic Surgery · 291d
Cleared Oct 04, 2002
PSA4000 EEG MONITOR WITH FRONTAL PSI
K020671 · OLW
Physiometrix, Inc.
Neurology · 217d
Cleared Oct 04, 2002
PMX COMPACT RESUCITATOR
K021390 · BTM
Cheen Houng Ent. Co. , Ltd.
Anesthesiology · 155d
Cleared Oct 04, 2002
NBD CEMENT RESTRICTOR DEVICE
K021788 · JDK
New Business Development, LLC
Orthopedic · 126d
Cleared Oct 04, 2002
AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
K022207 · MBI
Axya Medical, Inc.
Orthopedic · 88d
Cleared Oct 04, 2002
MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650
K022210 · MKJ
Cardiac Science, Inc.
Cardiovascular · 88d
Cleared Oct 04, 2002
VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006...
K022257 · DRC
Vomed Volzer Medizintechnik GmbH & Co.
Cardiovascular · 84d
Cleared Oct 04, 2002
KOKOMATE
K022276 · BZG
Ferraris Respiratory, Inc.
Anesthesiology · 81d
Cleared Oct 04, 2002
RHINOSTREAM RHINOMANOMETER MODULE
K022311 · BXQ
Rhino Metrics A/S
Anesthesiology · 79d
Cleared Oct 04, 2002
RHS ACETABULAR COMPONENT
K022382 · LPH
Signal Medical Corp.
Orthopedic · 74d
Cleared Oct 04, 2002
MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T
K023021 · HWC
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Oct 04, 2002
NUGEN FX SCREW
K023022 · HWC
Bionx Implants, Inc.
Orthopedic · 23d
Cleared Oct 04, 2002
SYNCHRON LX I 725 CLINICAL SYSTEM
K023049 · JGS
Beckman Coulter, Inc.
Chemistry · 22d
Cleared Oct 04, 2002
CLASSIC GREAT TOE IMPLANT
K023086 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 17d
Cleared Oct 04, 2002
CANON X-RAY DIGITAL CAMERA WITH ADDITIONAL SOFTWARE, LANMIX MLT
K023124 · MQB
Canon, Inc.
Radiology · 15d
Cleared Oct 03, 2002
INSULATION AND CONTINUITY TESTER PLUS ACCESSORIES
K020334 · GEI
Jac-Cell Medic Corporation
General & Plastic Surgery · 245d
Cleared Oct 03, 2002
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
K020810 · DAP
bioMerieux, Inc.
Hematology · 204d
Cleared Oct 03, 2002
RADIANALYZER, MODEL 12710
K022188 · DQK
Radi Medical Systems AB
Cardiovascular · 90d
Cleared Oct 03, 2002
DISPOSABLE N-PE MICROKERATOME BLADES
K022205 · HNO
Oasis Medical, Inc.
Ophthalmic · 90d
Cleared Oct 03, 2002
ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B
K022234 · HWC
Arthrex, Inc.
Orthopedic · 84d
Cleared Oct 03, 2002
AURORA SR
K022266 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 83d