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

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176,076 results
67897–67920 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 2004
NP-2600 SERIES HARDCOPY PRINTERS
K042232 · LMC
Codonics, Inc.
Radiology · 49d
Cleared Oct 05, 2004
SCANX 14
K042397 · MQB
Air Techniques, Inc.
Radiology · 33d
Cleared Oct 05, 2004
ZOLL M SERIES ETC02 LOFLO OPTION
K042417 · MKJ
Zoll Medical Corp
Cardiovascular · 28d
Cleared Oct 05, 2004
ADVENTURE A10
K042535 · ITI
Ulrich Alber GmbH
Physical Medicine · 15d
Cleared Oct 05, 2004
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K042651 · JIT
Beckman Coulter, Inc.
Toxicology · 7d
Cleared Oct 04, 2004
VARICES NEEDLE
K031238 · FBK
Scandimed. A.S.
Gastroenterology & Urology · 535d
Cleared Oct 04, 2004
BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR
K033589 · FMF
Micromedics, Inc.
General Hospital · 326d
Cleared Oct 04, 2004
ENDOMETRIAL SAMPLING SYRINGE
K040189 · HHK
Rocket Medical Plc
Obstetrics & Gynecology · 250d
Cleared Oct 04, 2004
NAVIGUS PASSIVE PROBE, MODEL NP-1000
K040334 · HAW
Image-Guided Neurologics, Inc.
Neurology · 236d
Cleared Oct 04, 2004
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
K040601 · KWZ
Exactech, Inc.
Orthopedic · 210d
Cleared Oct 04, 2004
PRECISION LIQUID OXYGEN SYSTEM
K041122 · BYJ
Precision Medical, Inc.
Anesthesiology · 158d
Cleared Oct 04, 2004
PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606
K041919 · FPA
Clinico
General Hospital · 80d
Cleared Oct 04, 2004
G-SCAN
K042236 · LNH
Esaote, S.P.A.
Radiology · 47d
Cleared Oct 04, 2004
MICROALBUMIN MULTI-CALIBRATOR SET
K042243 · JIX
Diagnostic Chemicals , Ltd.
Chemistry · 46d
Cleared Oct 04, 2004
BP-SPECT V1.O
K042258 · KPS
Syntermed, Inc.
Radiology · 45d
Cleared Oct 04, 2004
PRACTIX CONVENIO
K042368 · IZL
Philips Medical Systems North America...
Radiology · 34d
Cleared Oct 04, 2004
HDS INTRA-ORAL IMAGING SYSTEM
K042372 · MUH
Vatech Value Added Technology Co., Ltd.
Radiology · 34d
Cleared Oct 04, 2004
PHILIPS IU22 ULTRASOUND SYSTEM
K042540 · IYO
Philips Ultrasound, Inc.
Radiology · 14d
Cleared Oct 01, 2004
SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331
K040311 · GZJ
Shian Jia Meei Enterprise Co., Ltd.
Neurology · 235d
Cleared Oct 01, 2004
MENTAMOVE
K040849 · IPF
Cole & Associates
Physical Medicine · 183d
Cleared Oct 01, 2004
EXACTECH OPTETRAK UNICONDYLAR KNEE
K040889 · HRY
Exactech, Inc.
Orthopedic · 179d
Cleared Oct 01, 2004
INTRAUTERINE VENOGRAM NEEDLE SET
K041062 · LKF
Cook Urological, Inc.
Obstetrics & Gynecology · 161d
Cleared Oct 01, 2004
POWERED WHEELCHAIR, MODEL B-500
K041208 · ITI
Otto Bock Healthcare LP
Physical Medicine · 144d
Cleared Oct 01, 2004
POWERED WHEELCHAIR, MODEL B-600
K041210 · ITI
Otto Bock Healthcare LP
Physical Medicine · 144d