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
164137–164160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1981
CARDIFF ALDASORBER SYSTEM
K811703
William Harvey Life Products Corp.
Cardiovascular
Cleared Jun 15, 1981
CORB TM COUNTERROTATING BIOPSY NEEDLE
K811005 · HSZ
Zimmer, Inc.
Orthopedic · 62d
Cleared Jun 12, 1981
FIRM-A-TRON
K810634 · IPF
Biotron , Ltd.
Physical Medicine · 94d
Cleared Jun 12, 1981
HY-BOND POLYCARBOXYLATE CEMENT
K810764 · EMA
Shofu Dental Corp.
Dental · 81d
Cleared Jun 12, 1981
HY-BOND ZINC PHOSPHATE CEMENT
K810765 · EMA
Shofu Dental Corp.
Dental · 81d
Cleared Jun 12, 1981
INSTAFIL
K810795 · KPE
Instafil, Inc.
Chemistry · 81d
Cleared Jun 12, 1981
MEDAID
K810841 · GZJ
C.V.I., Inc.
Neurology · 77d
Cleared Jun 12, 1981
MINITONE
K810975 · IPF
Bloomex International, Inc.
Physical Medicine · 63d
Cleared Jun 12, 1981
PREFILLED PULSATOR SYRINGE
K811009 · FMF
Concord Laboratories, Inc.
General Hospital · 58d
Cleared Jun 12, 1981
SYPHGMOLOG
K811079 · DSK
Cardiodyne General, Inc.
Cardiovascular · 52d
Cleared Jun 12, 1981
IV SETS
K811107 · FPA
Critikon Company, LLC
General Hospital · 50d
Cleared Jun 12, 1981
DEL MAR AVIONICS MODELS 9400 & 9401
K811122 · DSI
Del Mar Avionics
Cardiovascular · 49d
Cleared Jun 12, 1981
SECHRIST INFANT VENTRILATOR MODEL IV-100
K811141 · CBK
Sechrist Industries, Inc.
Anesthesiology · 46d
Cleared Jun 12, 1981
KERMATH RADIOGRAPHIC HEAD STAND
K811215 · KPR
Kermath Mfg. Corp.
Radiology · 39d
Cleared Jun 12, 1981
HUMAN BLOOD IN ALSEVER'S
K811225 · JSK
Dutchland Laboratories, Inc.
Pathology · 39d
Cleared Jun 12, 1981
CATHETER MAINTENANCE KIT
K811247 · FRG
Clinipad Corp.
General Hospital · 38d
Cleared Jun 12, 1981
GC CULTURE MEDIUM
K811281 · JTY
Biolog, Inc.
Microbiology · 35d
Cleared Jun 12, 1981
SELECTIVE GC CULTURE MEDIUM
K811282 · JTY
Biolog, Inc.
Microbiology · 35d
Cleared Jun 12, 1981
JEMBEC TRANSPORT SYSTEM
K811283 · JTW
Biolog, Inc.
Microbiology · 35d
Cleared Jun 12, 1981
GC TTANSPORT SYSTEM
K811284 · JTW
Biolog, Inc.
Microbiology · 35d
Cleared Jun 12, 1981
GAMBRO PERITONEAL DIALYSIS FLUID LINES
K811294 · KDJ
Gambro, Inc.
Gastroenterology & Urology · 32d
Cleared Jun 12, 1981
BI-CRP LATEX TEST
K811374 · DCN
Biologics Intl., Inc.
Microbiology · 28d
Cleared Jun 12, 1981
BI-RA SLIDE TEST
K811375 · DHR
Biologics Intl., Inc.
Microbiology · 28d
Cleared Jun 12, 1981
CEA DESALTING DOLUMN SEPHADEX R
K811394 · DHX
Immuno-Diagnostic Laboratories
Chemistry · 25d