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
146713–146736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1985
THAYER-MARTIN MEDIUM (MOD)
K854275 · JTY
R. Kent Richards, Inc.
Microbiology · 25d
Cleared Nov 12, 1985
OPHALMIC LASER PHOTOCOAGULATOR
K854288 · HQF
Mira, Inc.
Ophthalmic · 18d
Cleared Nov 12, 1985
IRON
K854298 · CEM
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Nov 12, 1985
KEYMED OFFICE COUCH
K854304 · FPO
Keymed, Inc.
General Hospital · 18d
Cleared Nov 12, 1985
DART IRON & IRON BINDING CAPACITY REAGENT
K854305 · CFM
Coulter Electronics, Inc.
Chemistry · 18d
Cleared Nov 12, 1985
SIOM
K854343 · HQZ
South West Intl., Inc.
Ophthalmic · 14d
Cleared Nov 12, 1985
KERATOLUX
K854383 · HPL
Carl Zeiss, Inc.
Ophthalmic · 13d
Cleared Nov 08, 1985
CARDIO METRICS INVASIVE PRESSURE MONIT
K841960 · DRS
Sterile Design, Inc.
Cardiovascular · 543d
Cleared Nov 08, 1985
KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR
K851627 · DRW
Eaton Medical Group
Cardiovascular · 204d
Cleared Nov 08, 1985
PCX-100 PATIENT INPUT LEADWIRE
K851632 · DRW
Eaton Medical Group
Cardiovascular · 204d
Cleared Nov 08, 1985
SUPRIMA MODEL 254-22
K852339 · DXY
Intermedics, Inc.
Cardiovascular · 158d
Cleared Nov 08, 1985
SUPRIMA MODEL 254-24
K852340 · DXY
Intermedics, Inc.
Cardiovascular · 158d
Cleared Nov 08, 1985
ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9
K852534 · FTC
R. A. Fischer Co. Corp.
General & Plastic Surgery · 147d
Cleared Nov 08, 1985
NEO SHIELD
K852943 · FMT
Gaymar Industries, Inc.
General Hospital · 120d
Cleared Nov 08, 1985
INTEGRATED DISPLAY TECHNOLOGY LTD.
K853130 · FLL
Integrated Display Technology, Ltd.
General Hospital · 105d
Cleared Nov 08, 1985
OE SERIES OF BEHIND-THE-EAR HEARING AIDS
K853381 · ESD
Emtech Laboratories
Ear, Nose, Throat · 88d
Cleared Nov 08, 1985
TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS
K853444 · JAK
Toshiba Medical Systems
Radiology · 84d
Cleared Nov 08, 1985
DIGITAL THERMOMETER
K853824 · FLL
Epson America, Inc.
General Hospital · 56d
Cleared Nov 08, 1985
ALPHA CHUCK
K853970 · KME
Rocky Mountain Medical Corp.
General Hospital · 43d
Cleared Nov 08, 1985
MICROTHERM MT-501 & MT-502
K854007 · FLL
Medequi, Division of King Yip Co., Inc.
General Hospital · 39d
Cleared Nov 08, 1985
PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT
K854084 · FKL
Organon Teknika Corp.
Gastroenterology & Urology · 32d
Cleared Nov 08, 1985
EXPRESS TAN SUN CANOPY
K854111 · FTC
Sunmaker Tanning Systems, Ltd.
General & Plastic Surgery · 31d
Cleared Nov 08, 1985
PHASE V-MODEL 1500 RUVA
K854131 · FTC
Apollo'S Suntanning Supplies
General & Plastic Surgery · 29d
Cleared Nov 08, 1985
FOX BED MODEL 2001
K854154 · FTC
Ace Mfg.
General & Plastic Surgery · 28d