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
141625–141648 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1987
HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST
K864929 · HWE
Hall Surgical, Division of Zimmer, Inc.
Orthopedic · 43d
Cleared Jan 28, 1987
'EXMOOR' SHAH SILICONE DISCS
K864934 · EPP
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 43d
Cleared Jan 28, 1987
'EXMOOR' SHAH PACKING STRIPS
K864935
Exmoor Plastics , Ltd.
General & Plastic Surgery · 43d
Cleared Jan 28, 1987
GUO GUANG WHEEL CHAIR
K870043 · IOR
China National Medicines & Health...
Physical Medicine · 23d
Cleared Jan 28, 1987
RD 140 SURGICAL BENDER
K870084 · HXW
Terray Manufacturing, Inc.
Orthopedic · 20d
Cleared Jan 28, 1987
PLASTER STAND
K870100 · LGG
Orthopedic Systems, Inc.
Orthopedic · 19d
Cleared Jan 27, 1987
TECA NEUROPTO WITH OS-5 STIMULATOR
K861069 · GWE
Teca, Inc.
Neurology · 313d
Cleared Jan 27, 1987
REGULATOR OXYGEN MECHANICAL
K863711 · CAN
Lifeguard Medical Products, Inc.
Anesthesiology · 126d
Cleared Jan 27, 1987
WHITESIDE ORTHOLOC (TM)
K864070 · HRY
Dow Corning Wright
Orthopedic · 99d
Cleared Jan 27, 1987
280SL IMAGING SYSTEM SMALL PARTS PROBES
K864135 · ITX
Ge Medical Systems Information...
Radiology · 98d
Cleared Jan 27, 1987
260SL IMAGING SYSTEM SMALL PARTS PROBES
K864136 · ITX
Ge Medical Systems Information...
Radiology · 98d
Cleared Jan 27, 1987
NARKOMED 2B ANESTHESIA SYSTEM
K864447 · BSZ
Draeger Medical, Inc.
Anesthesiology · 76d
Cleared Jan 27, 1987
O.B.(TM) TAMPON
K864498 · HIL
Personal Products Co.
Obstetrics & Gynecology · 74d
Cleared Jan 22, 1987
DUNN ANTERIOR DISTRACTION SYSTEM
K862755
Osteotek, Inc.
Orthopedic · 184d
Cleared Jan 21, 1987
WELLCOZYME ROTAVIRUS WZ01
K861628 · LIQ
Wellcome Diagnostics
Microbiology · 267d
Cleared Jan 21, 1987
NOVOPEN SYSTEM (INSULIN SYRINGE)
K861686 · FMF
Squibb-Novo, Inc.
General Hospital · 264d
Cleared Jan 21, 1987
CHALLENGE ORTHODONTIC BONDING ADHESIVE
K863709 · DYH
Ormco Corp.
Dental · 120d
Cleared Jan 21, 1987
AMYLASE REAGENT
K864356 · CIJ
Trace Scientific , Ltd.
Chemistry · 79d
Cleared Jan 21, 1987
BECKMAN EPSILON(TM) PROLACTIN TEST KIT
K864439 · CFT
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Jan 21, 1987
PSI AMYLASE REAGENT
K864464 · JFJ
Pointe Scientific, Inc.,
Chemistry · 70d
Cleared Jan 21, 1987
IL TEST 84668-15, FACTOR VIII CONTROL PLASMA
K864480 · GGP
Instrumentation Laboratory CO
Hematology · 69d
Cleared Jan 21, 1987
BT HYPODERMIC SYRINGE
K864541 · FMF
Baron Technologies, Inc.
General Hospital · 63d
Cleared Jan 21, 1987
APPLIDYN
K864581 · ISD
Grandcor Medical Systems
Physical Medicine · 62d
Cleared Jan 21, 1987
PENOX HOSPITAL BED
K864667 · FNJ
Penox Technologies, Inc.
General Hospital · 50d