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

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175,820 results
37249–37272 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2014
SILVERLON ISLAND WOUND DRESSING
K141573 · FRO
Argentum Medical
General & Plastic Surgery · 77d
Cleared Aug 28, 2014
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7
K141821 · LZO
Exactech, Inc.
Orthopedic · 52d
Cleared Aug 28, 2014
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER...
K142080 · LHC
Ecolab, Inc.
General Hospital · 28d
Cleared Aug 28, 2014
NIO -INTRAOSSEOUS DEVICE
K142086 · FMI
Waismed, Ltd.
General Hospital · 28d
Cleared Aug 28, 2014
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
K142120 · FZP
AtriCure, Inc.
General & Plastic Surgery · 24d
Cleared Aug 28, 2014
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
K142135 · HRS
Icon Orthopedic Concepts, LLC Dba...
Orthopedic · 24d
Cleared Aug 28, 2014
TOTAL SHIELD SURGICAL
K142166 · FYA
Zimmer, Inc.
General Hospital · 29d
Cleared Aug 27, 2014
PREVANTICS DEVICE SWAB
K132380 · LKB
Professional Disposables...
General Hospital · 392d
Cleared Aug 27, 2014
JETSTREAM XC 2.4/3.4
K133023 · MCW
Medrad, Inc.
Cardiovascular · 335d
Cleared Aug 27, 2014
STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
K133549 · FRC
Steritec Products Mfg Co, Inc.
General Hospital · 281d
Cleared Aug 27, 2014
MINNCARE HD
K133724 · NIH
Medivators, Inc.
General Hospital · 264d
Cleared Aug 27, 2014
CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER...
K140338 · DYB
Creganna-Tactx Medical
Cardiovascular · 198d
Cleared Aug 27, 2014
GENESIS REUSABLE RIGID CONTAINER SYSTEM
K140850 · KCT
Carefusion 2200, Inc.
General Hospital · 146d
Cleared CT Aug 27, 2014
MONICA NOVII WIRELESS PATCH SYSTEM
K140862 · OSP
Monica Healthcare, Ltd.
Obstetrics & Gynecology · 146d
Cleared Aug 27, 2014
ALL-CERAMIC ZIRCONIA BLOCK
K141162 · EIH
Rizhao Huge Dental Industry Co., Ltd.
Dental · 114d
Cleared Aug 27, 2014
DOSELAB PRO
K141230 · IYE
Mobius Medical Systems, LP
Radiology · 106d
Cleared Aug 27, 2014
LITONG POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES
K141239 · LYZ
Zibo Litong Plastic Products Co., Ltd.
General Hospital · 106d
Cleared Aug 27, 2014
RICHFUL POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K141305 · LYZ
Shijiazhuang Richful Plastic Co., Ltd.
General Hospital · 100d
Cleared Aug 27, 2014
AOK POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K141307 · LYZ
Shijiazhuang Aok Plastic Co., Ltd.
General Hospital · 100d
Cleared Aug 27, 2014
CIANNA MEDICAL SGS SYSTEM
K141318 · PDW
Cianna Medical, Inc.
Radiology · 99d
Cleared Aug 27, 2014
OPAL CHIRO, 20/20 P-DR
K141435 · MQB
2020 Imaging
Radiology · 89d
Cleared Aug 27, 2014
PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM
K141762 · FMF
Biomet, Inc.
General Hospital · 57d
Cleared Aug 26, 2014
VERITRACT ENTERAL FEEDING TUBE SYSTEM
K133334 · KNT
Veritract, Inc.
Gastroenterology & Urology · 301d
Cleared Aug 26, 2014
SLIT LAMP SL-D701
K133667 · HJO
Topcon Corp.
Ophthalmic · 270d