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
41833–41856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 2013
SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE
K123815 · JAQ
Varian Medical Systems, Inc.
Radiology · 89d
Cleared Mar 11, 2013
AAP RADIUS SET 2.5
K123875 · HRS
Aap Implantate AG
Orthopedic · 84d
Cleared Mar 11, 2013
PICCOLO LACTATE TEST SYSTEM
K130113 · KHP
Abaxis, Inc.
Chemistry · 54d
Cleared Mar 11, 2013
STEREOS WORKSTATION
K130395 · LLZ
Eos Imaging, Inc.
Radiology · 24d
Cleared Mar 08, 2013
REVOIS IMPLANT SYSTEM
K113042 · DZE
Riemser Arzneimittel AG
Dental · 513d
Cleared Mar 08, 2013
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
K113636 · CGA
Philosys Co., Ltd.
Chemistry · 455d
Cleared Mar 08, 2013
ORAVAN OSA
K121285 · LRK
New Jersey Snoring Solutions
Dental · 312d
Cleared Mar 08, 2013
QUIDEL MOLECULAR RSV + HMPV ASSAY
K122189 · OEM
Quidel Corp.
Microbiology · 227d
Cleared Mar 08, 2013
SYNOVIS COLLAGEN MATRIX (TBD)
K122306 · DXZ
Synovis Surgical Innovations
Cardiovascular · 219d
Cleared Mar 08, 2013
ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION...
K122468 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 207d
Cleared Mar 08, 2013
ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
K122469 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 207d
Cleared Mar 08, 2013
IMAGE WORKS PANOURA
K122806 · MUH
Mic International
Radiology · 176d
Cleared Mar 08, 2013
ENDOSEE MODEL 8000 U-SCOPE
K123151 · HIH
Endosee Corp
Obstetrics & Gynecology · 150d
Cleared Mar 08, 2013
ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
K123212 · PDG
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 144d
Cleared Mar 08, 2013
INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
K123228 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 144d
Cleared Mar 08, 2013
FASTPACK CONTROL KIT
K123725 · JJY
Qualigen, Inc.
Chemistry · 94d
Cleared Mar 08, 2013
POLARIS 100/200
K123776 · FTD
Drager Medical GmbH
General & Plastic Surgery · 88d
Cleared Mar 08, 2013
QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
K123955 · OOI
Life Technologies Corporation
Microbiology · 77d
Cleared Mar 08, 2013
QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
K123998 · OZN
Quidel Corp.
Microbiology · 72d
Cleared Mar 08, 2013
UNI-PICC
K130034 · LJS
Health Line International Corporation
General Hospital · 60d
Cleared Mar 08, 2013
TRINITY ACETABULAR SYSTEM
K130128 · LZO
Corin Medical
Orthopedic · 50d
Cleared Mar 07, 2013
MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
K121511 · FPA
Maclin Power, Inc.
General Hospital · 290d
Cleared Mar 07, 2013
LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
K122476 · NUC
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 205d
Cleared Mar 07, 2013
BONOS R GENTA 1X20 MODEL 01-0228
K123081 · LOD
Aap Biomaterials GmbH & Co. KG
Orthopedic · 157d