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
156625–156648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 1983
SOLARCRY/TEMPORARY CROWN & BRIDGE MAT
K831294 · EBG
Solar Dental Co., Inc.
Dental · 133d
Cleared Aug 31, 1983
RAPID ATRIAL PACER
K831381 · DTE
Seamed Corp.
Cardiovascular · 125d
Cleared Aug 31, 1983
COLLINS DS
K831777 · BZC
Warren E. Collins, Inc.
Anesthesiology · 90d
Cleared Aug 31, 1983
RS-RESIDUAL VOLUME SYSTEM
K831778 · BZC
Warren E. Collins, Inc.
Anesthesiology · 90d
Cleared Aug 31, 1983
JEJUNOSTOMY KIT
K831847 · KNT
Accu-Line
Gastroenterology & Urology · 84d
Cleared Aug 31, 1983
LEADING EDGE OPHTHALMIC KNIFE
K831975 · HNN
Surgidev Corp.
Ophthalmic · 72d
Cleared Aug 31, 1983
EMBOLECTOMY CATHETER
K832023 · DXE
Bionomy, Inc.
Cardiovascular · 79d
Cleared Aug 31, 1983
LIGHT CURING BONDING AGENT
K832061 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 65d
Cleared Aug 31, 1983
ADAPTIC*FAST SET DENTAL RESTORATIVE
K832062 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 65d
Cleared Aug 31, 1983
NO-MIX 30 ORTHODONTIC BONDING SYSTEM
K832112 · DYH
Scientific Pharmaceuticals, Inc.
Dental · 62d
Cleared Aug 31, 1983
NICE PACK
K832193 · IME
Universal Medical Instrument Corp.
Physical Medicine · 54d
Cleared Aug 31, 1983
PRO PULSE PERIODONTAL IRRIGATOR 7618
K832222 · EFS
Vipont Laboratories, Inc.
Dental · 54d
Cleared Aug 31, 1983
PERIODONTAL IRRIGATOR #7620
K832223 · EFS
Vipont Laboratories, Inc.
Dental · 54d
Cleared Aug 31, 1983
SIGMA PROCEDURE #550 DETERM. BILIRUB
K832236 · CIG
Sigma Chemical Co.
Chemistry · 51d
Cleared Aug 31, 1983
NEUROMOD COMFORT WAVE #7721 DUAL-
K832238 · GZJ
Medtronic Vascular
Neurology · 51d
Cleared Aug 31, 1983
X-704
K832253 · EJS
Unitek Corp.
Dental · 51d
Cleared Aug 31, 1983
AUTO-TACH
K832291 · DYH
Dentsply Intl.
Dental · 49d
Cleared Aug 31, 1983
S2MEDIAN
K832295 · GXY
Anstek Corp.
Neurology · 49d
Cleared Aug 31, 1983
S2 POSTERIOR-TIB
K832296 · GXY
Anstek Corp.
Neurology · 49d
Cleared Aug 31, 1983
DIRECT BONDED BRACKET REMOVER
K832301 · JCX
Northwest Orthopedics
General & Plastic Surgery · 49d
Cleared Aug 31, 1983
BRAEGEN III 10-CHANNEL TRANSMITTER-
K832304 · GYE
Electro-Bio-Medical Services, Inc.
Neurology · 48d
Cleared Aug 31, 1983
PRISMA III
K832320 · EBZ
Dentsply Intl.
Dental · 47d
Cleared Aug 31, 1983
STRATUS AMIKACIN FLUOROMETRIC
K832336 · KLQ
American Dade
Chemistry · 44d
Cleared Aug 31, 1983
AUTO-TENS MODEL V
K832337 · GZJ
Cbc Corp.
Neurology · 44d