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
57337–57360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2008
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM
K073065 · KWD
Osteomed LP
Orthopedic · 114d
Cleared Feb 21, 2008
DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
K073072 · JHM
Dade Behring, Inc.
Chemistry · 113d
Cleared Feb 21, 2008
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND...
K073184 · HQD
Bausch & Lomb, Inc.
Ophthalmic · 100d
Cleared Feb 21, 2008
HEANY INDUSTRIES INC DENTAL XIRCONIA
K073314 · EIH
Heany Industries, Inc.
Dental · 87d
Cleared Feb 21, 2008
NEWDEAL TIBIAXYS SYSTEM
K073375 · HRS
Newdeal Sas
Orthopedic · 80d
Cleared Feb 21, 2008
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K073460 · HRS
Synthes (Usa)
Orthopedic · 73d
Cleared Feb 21, 2008
DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR...
K073516 · BSP
Kyphon, Inc.
Anesthesiology · 69d
Cleared Feb 21, 2008
DEPUY TRI-LOCK BONE PRESERVATION STEM
K073570 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Feb 21, 2008
I-DIXEL
K073704 · LLZ
J. Morita USA, Inc.
Radiology · 52d
Cleared Feb 21, 2008
CLEARSCAN
K080119 · ITX
Esi, Inc.
Radiology · 35d
Cleared Feb 21, 2008
PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300
K080320 · LLZ
Nds Surgical Imaging
Radiology · 15d
Cleared Feb 21, 2008
INSTARAD
K080334 · LLZ
Medsphere Technologies Pvt , Ltd.
Radiology · 14d
Cleared Feb 20, 2008
EASYRA CHOLESTEROL REAGENT
K072249 · CHH
Medica Corp.
Chemistry · 191d
Cleared Feb 20, 2008
VITREA 4DCT
K072821 · LLZ
Vital Images, Inc.
Radiology · 141d
Cleared Feb 20, 2008
POLYSTAR 79 DENTURE BASE RESIN
K072851 · EBI
Cmp Industries, LLC
Dental · 139d
Cleared Feb 20, 2008
INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX
K073232 · KWQ
Spinefrontier, Inc.
Orthopedic · 97d
Cleared Feb 20, 2008
GC GAM-100
K073283 · EMA
GC America, Inc.
Dental · 91d
Cleared Feb 19, 2008
ALPHA INFUSION PUMP, MODEL A200, A450
K071532 · MEB
Advanced Infusion, Inc.
General Hospital · 259d
Cleared Feb 19, 2008
UNICOMPARTMENTAL KNEE
K072704 · HRY
Valpo Orthopedic Technology, Inc.
Orthopedic · 148d
Cleared Feb 19, 2008
DVO EXTENDED ARTICULATION HUMERAL HEADS
K073331 · HSD
Dvo Extremity Solutions, LLC
Orthopedic · 84d
Cleared Feb 19, 2008
ORTHOPEDIATRICS PLATING SYSTEM
K073344 · HRS
Orthopediatrics, LLC
Orthopedic · 83d
Cleared Feb 19, 2008
APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM
K073426 · HWC
Cayenne Medical, Inc.
Orthopedic · 76d
Cleared Feb 15, 2008
GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE
K062991 · OHS
Light Bioscience, LLC
General & Plastic Surgery · 504d
Cleared Feb 15, 2008
POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7
K071596 · IRP
Nihon Seimitsu Sokki Co., Ltd.
Physical Medicine · 248d