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
148369–148392 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 1985
KETTLER ULTRAVIOLET SUNTANNING BENCHES & LIFTS
K852243 · FTC
Mottek Intl. Corp.
General & Plastic Surgery · 35d
Cleared Jun 27, 1985
STILLE BONE CUTTING RORCEPS 10 1/4 IN SS 420 & 416
K852245
The Huxley Instrument Corp.
General & Plastic Surgery · 35d
Cleared Jun 27, 1985
870 SURGICAL SYS CONTROL PULSE MODIFICATION
K852252 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 33d
Cleared Jun 27, 1985
SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER
K852258
Kleen Test Products
General & Plastic Surgery · 34d
Cleared Jun 27, 1985
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K852263 · DHB
Pharmacia, Inc.
Immunology · 34d
Cleared Jun 27, 1985
CATAPRESS TOURNIGUET
K852277 · GAX
Boehringer Ingelheim Pharmaceuticals,...
General & Plastic Surgery · 29d
Cleared Jun 27, 1985
RETRACTOR, SURGICAL
K852330 · GAD
Scholten Surgical Instruments, Inc.
General & Plastic Surgery · 27d
Cleared Jun 27, 1985
PHILIPS SOLARIUM HP 3134
K852348 · FTC
Philips Int'L B.V.
General & Plastic Surgery · 27d
Cleared Jun 27, 1985
MANAN TROCAR STYLE BIOPSY NEEDLE
K852426 · GAA
Manan Manufacturing Co., Inc.
General & Plastic Surgery · 20d
Cleared Jun 27, 1985
MANAN SPINAL NEEDLE
K852427 · GAA
Manan Manufacturing Co., Inc.
General & Plastic Surgery · 20d
Cleared Jun 27, 1985
MANAN EPIDURAL NEEDLE
K852428 · GCB
Manan Manufacturing Co., Inc.
General & Plastic Surgery · 20d
Cleared Jun 27, 1985
INFUSAFE 205 CATOLOG NO. 205.000
K852433 · FLN
Medix Medical Electronics (U.S.A.), Inc.
General Hospital · 17d
Cleared Jun 27, 1985
CONTROLLED RELEASE INFUSION SYSTEM(CRIS)
K852488 · FPA
Y
General Hospital · 20d
Cleared Jun 26, 1985
MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
K844252 · DXN
Medtronic Vascular
Cardiovascular · 236d
Cleared Jun 26, 1985
TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600
K845036 · LCJ
Progress Mankind Technology
General & Plastic Surgery · 181d
Cleared Jun 26, 1985
ANSELL NO POWDER SURGEON'S GLOVES
K850635 · KGO
Ansell, Inc.
General Hospital · 127d
Cleared Jun 26, 1985
GUIDE, WIRE, ANGIOGRAPHIC
K850827 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 26, 1985
WIRE, GUIDE - MODIFICATION
K850828 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 26, 1985
WIRE, GUIDE, CATHETER
K850829 · DQY
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 26, 1985
ALBUMIN
K850931 · CIX
Dilab, Inc.
Chemistry · 111d
Cleared Jun 26, 1985
CARDIOSTAT 3 RECORDER
K851044 · DPS
Siemens Elema AB
Cardiovascular · 104d
Cleared Jun 26, 1985
SIRECUST 420 PATIENT DIALOG MONITOR
K851400 · DXJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 78d
Cleared Jun 26, 1985
SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE
K851626 · DSF
Eaton Medical Group
Cardiovascular · 69d
Cleared Jun 26, 1985
CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL
K851633 · DPS
Eaton Medical Group
Cardiovascular · 69d