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
67249–67272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 2004
SYSTEMP.C&B PLUS
K042820 · EBG
Ivoclar Vivadent, Inc.
Dental · 63d
Cleared Dec 14, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042962 · NKB
Medtronic Sofamor Danek
Orthopedic · 48d
Cleared Dec 14, 2004
SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K043190 · NHA
Innova Life Sciences Corp.
Dental · 27d
Cleared Dec 14, 2004
ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
K043337 · HWC
Arthrex, Inc.
Orthopedic · 11d
Cleared Dec 13, 2004
OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
K033973 · NLF
Nellcor Puritan Bennett, Inc.
Anesthesiology · 357d
Cleared Dec 13, 2004
HELICOBACTER PYLORI IGG ELISA
K041238 · LYR
Biohit Plc
Microbiology · 216d
Cleared Dec 13, 2004
ML830 LASER SYSTEM
K041364 · ILY
Microlight Corporation of America
Physical Medicine · 206d
Cleared Dec 13, 2004
REUSABLE STERILCONTAINER FILTER MODEL #JK090
K041623 · FRG
Aesculap, Inc.
General Hospital · 180d
Cleared Dec 13, 2004
DAPTOMYCIN
K042392 · JWY
Ab Biodisk
Microbiology · 102d
Cleared Dec 13, 2004
6F Z4 GUIDE CATHETER
K042489 · DQY
Medtronic Vascular
Cardiovascular · 90d
Cleared Dec 13, 2004
BIOCARE SYSTEMS PREMIR 818
K042532 · ILY
Biocare Systems, Inc.
Physical Medicine · 87d
Cleared Dec 13, 2004
EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE
K042772 · NKB
Ebi, L.P.
Orthopedic · 69d
Cleared Dec 13, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
K042963 · LON
bioMerieux, Inc.
Microbiology · 47d
Cleared Dec 13, 2004
MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM
K043062 · IZL
Source-Ray, Inc.
Radiology · 38d
Cleared Dec 13, 2004
PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
K043092 · EHD
Progeny, Inc.
Radiology · 34d
Cleared Dec 13, 2004
METRX WORKSTATION
K043134 · LLZ
Medical Metrx Solutions, Inc.
Radiology · 31d
Cleared Dec 13, 2004
ALL FLOW PULMONARY FUNCTION FILTER
K043148 · CAH
Alliance Tech Medical, Inc.
General Hospital · 28d
Cleared Dec 13, 2004
TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES
K043278 · ITX
Teratech Corp.
Radiology · 17d
Cleared Dec 13, 2004
WHEELCHAIR, MODEL 8500-II
K043332 · IOR
Cycling and Health Tech. Industry R&D...
Physical Medicine · 11d
Cleared Dec 10, 2004
VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR
K032825 · DXN
Mars Medical Products Co., Ltd.
Cardiovascular · 457d
Cleared Dec 10, 2004
ARTHREX SUTURE GRAFTING KIT
K041553 · GAT
Arthrex, Inc.
General & Plastic Surgery · 184d
Cleared Dec 10, 2004
CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER
K041833 · FLE
Consolidated Machine Corp.
General Hospital · 156d
Cleared Dec 10, 2004
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
K042099 · HKX
Retinapharma Technologies, Inc.
Ophthalmic · 128d
Cleared Dec 10, 2004
PROMEDICAL SURGICAL GOWNS
K042111 · FYA
Promedical Products Co., Ltd.
General Hospital · 127d