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
47641–47664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 2011
SOLCART B
K102194 · KPO
B. Braun Avitum AG
Gastroenterology & Urology · 264d
Cleared Apr 25, 2011
PROTECTIVE RESTRAINT
K110377 · FMQ
Medi-Tech Intl. Corp.
General Hospital · 75d
Cleared Apr 22, 2011
AVS ANCHOR-C CERVICAL CAGE SYSTEM
K102606 · OVE
Stryker Spine
Orthopedic · 224d
Cleared Apr 22, 2011
RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR
K102902 · LYY
Rubbercare Protection Products Sdn Bhd
General Hospital · 204d
Cleared Apr 22, 2011
GSP NEONATAL THYROXINE (T4)
K103484 · KLI
Wallac Oy, A Subsidiary of...
Chemistry · 147d
Cleared Apr 22, 2011
POSEY BED
K103817 · OYS
J. T. Posey Co.
General Hospital · 114d
Cleared Apr 22, 2011
VENX REVOLUTION
K110355 · GAH
Venx, LLC
General & Plastic Surgery · 74d
Cleared Apr 22, 2011
C.T.M. MOBILITY SCOOTER - MODEL HS 118
K110395 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 70d
Cleared Apr 22, 2011
C.T.M. MOBILITY SCOOTER HS515(3W)
K110567 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 53d
Cleared Apr 22, 2011
WINCO STRETCHAIR
K110671 · INK
Winco Mfg., LLC
Physical Medicine · 44d
Cleared Apr 22, 2011
REVISION PROTHESIS
K110837 · JWH
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Apr 21, 2011
BODYFLOW P2CH
K100862 · IPF
Physiomed Elektromedizin AG
Physical Medicine · 388d
Cleared Apr 21, 2011
INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM
K103194 · DZE
Intra-Lock International, Inc.
Dental · 174d
Cleared Apr 21, 2011
PRECISION LIQUID OXYGEN SYSTEM
K103324 · BYJ
Precision Medical, Inc.
Anesthesiology · 160d
Cleared Apr 21, 2011
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY...
K103602 · LYY
Medline Industries, Inc.
General Hospital · 134d
Cleared Apr 21, 2011
XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM...
K103766 · OQW
Cepheid
Microbiology · 119d
Cleared Apr 21, 2011
SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
K103770 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 115d
Cleared Apr 21, 2011
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
K110125 · HRS
Synthes (Usa)
Orthopedic · 93d
Cleared Apr 21, 2011
CURVE IMAGE
K110139 · LLZ
Curve Dental, Inc.
Radiology · 93d
Cleared Apr 21, 2011
HELENA SYSTEM
K110177 · MAX
Royal Oak Medical Devices
Orthopedic · 90d
Cleared Apr 21, 2011
EASYRA UREA NITROGEN AND CREATININE REAGENTS
K110675 · CDQ
Medica Corp.
Chemistry · 42d
Cleared Apr 21, 2011
TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)
K110787 · MQV
Orthogem Limited
Orthopedic · 31d
Cleared Apr 21, 2011
IFUSE IMPLANT SYSTEM
K110838 · OUR
SI-BONE, Inc.
Orthopedic · 27d
Cleared Apr 21, 2011
JETPACK 2.0
K111024 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 9d