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
44473–44496 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 2012
ORTHOLOC 3DI HALLUX SYSTEM
K120359 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared May 03, 2012
HALO90 ULTRA ABLATION CATHETER
K120431 · GEI
Barrx Medical, Inc.
General & Plastic Surgery · 80d
Cleared May 03, 2012
3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM
K120704 · DRG
3M Company
Cardiovascular · 56d
Cleared May 03, 2012
ES FLOW
K120768 · EBF
Spident Co., Ltd.
Dental · 50d
Cleared May 03, 2012
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
K121006 · MTD
St Jude Medical
Cardiovascular · 30d
Cleared May 03, 2012
VIPER SYSTEM
K121020 · NKB
Depuy Spine, Inc.
Orthopedic · 29d
Cleared May 03, 2012
LOSPA TIBIAL BASE PLATE
K121037 · JWH
Corentec Co., Ltd.
Orthopedic · 28d
Cleared May 03, 2012
VIALOK NON-VENTED
K121182 · LHI
Yukon Medical, LLC
General Hospital · 15d
Cleared May 03, 2012
ENDO CLIP III 5MM CLIP APPLIER
K121194 · FZP
Covidien
General & Plastic Surgery · 14d
Cleared May 02, 2012
MICROWARE BONE PLATES AND BONE SCREW
K111008 · HRS
Microware Precision Co., Ltd.
Orthopedic · 387d
Cleared May 02, 2012
JIAJIAN TENS
K112288 · GZJ
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 267d
Cleared May 02, 2012
RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY...
K112924 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 212d
Cleared May 02, 2012
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S...
K113088 · GWM
Innerspace, Inc.
Neurology · 196d
Cleared May 02, 2012
POSEY BED
K113355 · OYS
J. T. Posey Co.
General Hospital · 170d
Cleared May 02, 2012
ECHOSTAR SPICA 1.5T MR SYSTEM
K113511 · LNH
Alltech Medical Systems America, Inc.
Radiology · 156d
Cleared May 02, 2012
ZELTIQ COOLSCULPTING
K120023 · OOK
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 120d
Cleared May 02, 2012
LULLABY LED PHOTTHERAPY SYSTEM
K120168 · LBI
Wipro GE Healthcare Private, Ltd.
General Hospital · 104d
Cleared May 02, 2012
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE...
K120184 · LZA
Encompass Medical Supplies Inc Limited
General Hospital · 100d
Cleared May 02, 2012
PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION...
K120261 · FPA
Perouse Medical
General Hospital · 96d
Cleared May 02, 2012
FLASH (DIFFERENT MATERIALS)
K120438 · ELW
3M Deutschland GmbH
Dental · 79d
Cleared May 02, 2012
OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR
K120978 · HSB
Merete Medical GmbH
Orthopedic · 30d
Cleared May 02, 2012
1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC
K120980 · LJS
Medical Components, Inc.
General Hospital · 30d
Cleared May 02, 2012
2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
K120981 · LJS
Medical Components, Inc.
General Hospital · 30d
Cleared May 02, 2012
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K120983 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 30d