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
147361–147384 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1985
QCA ENZYMATIC GLUCOSE
K853656 · CGA
Bd Becton Dickinson Vacutainer...
Chemistry · 13d
Cleared Sep 16, 1985
TDX REA BUN
K853677 · CDQ
Abbott Laboratories
Chemistry · 12d
Cleared Sep 16, 1985
PRECEPT TM CARBENICILLIN
K853685 · LTW
Austin Biological Laboratories
Microbiology · 178d
Cleared Sep 16, 1985
PRECEPT METHICILLIN
K853772 · LTW
Austin Biological Laboratories
Microbiology · 147d
Cleared Sep 15, 1985
TEMPORARY PACEMAKER GROUND WIRE
K852119 · DTB
Scholten Surgical Instruments, Inc.
Cardiovascular · 123d
Cleared Sep 13, 1985
OPHTHASCAN B
K844686 · IYO
Biophysic Medical, Inc.
Radiology · 284d
Cleared Sep 13, 1985
PRECEPT TM MEZLOCILLIN
K850833 · JWY
Austin Biological Laboratories
Microbiology · 196d
Cleared Sep 13, 1985
NEOS - M ABP
K853058 · DXY
Biotronik Sales, Inc.
Cardiovascular · 56d
Cleared Sep 13, 1985
CHALLENGER SUNRISE
K853248 · FTC
Challenge Products, Inc.
General & Plastic Surgery · 44d
Cleared Sep 13, 1985
600/L 5X6' UVA 85W LAMPS, 5X5 UVA 65W LAMPS 500/L
K853394 · FTC
Interlab(Electromechanical)
General & Plastic Surgery · 32d
Cleared Sep 13, 1985
PRECEPT KANAMYCIN
K853684 · LTW
Austin Biological Laboratories
Microbiology · 175d
Cleared Sep 13, 1985
PRECEPT TM AMIKACIN
K853686 · LTW
Austin Biological Laboratories
Microbiology · 175d
Cleared Sep 13, 1985
PRECEPT NETILMICIN 32-13
K853687 · LTW
Austin Biological Laboratories
Microbiology · 196d
Cleared Sep 13, 1985
PRECEPT TM TOBRAMYCIN
K853688 · LTW
Austin Biological Laboratories
Microbiology · 196d
Cleared Sep 13, 1985
PRECEPT TM MOXALACTAM
K853689 · LTW
Austin Biological Laboratories
Microbiology · 196d
Cleared Sep 12, 1985
NORELCO ELECTRONIC DIGITAL BP METER HC3501
K852128 · DXN
Philips Park
Cardiovascular · 120d
Cleared Sep 12, 1985
ORTHO DNA PROBE HSV CONFIRMATION TEST
K852360 · GQL
Ortho Diagnostic Systems, Inc.
Microbiology · 100d
Cleared Sep 12, 1985
MODEL 78560A CENTRAL STATION PATIENT INFO SYS
K852514 · DSI
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Sep 12, 1985
EXTERNAL PACEMAKER TELECTRONICS TE200
K852746 · JOQ
Seamed Corp.
Cardiovascular · 77d
Cleared Sep 12, 1985
TRIOS - M
K853057 · DXY
Biotronik Sales, Inc.
Cardiovascular · 55d
Cleared Sep 12, 1985
IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW
K853206 · DXY
Telectronics, Inc.
Cardiovascular · 43d
Cleared Sep 12, 1985
PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE
K853207 · KOD
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 43d
Cleared Sep 12, 1985
ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES
K853312 · DWO
Argon Medical Corp.
General & Plastic Surgery · 36d
Cleared Sep 12, 1985
SPR 2 AUTODILUTER
K853380 · JTC
Scientific Sales Intl., Inc.
Microbiology · 31d