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

Filters: Cleared only ×
176,076 results
169993–170016 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 06, 1979
DRUG ABUSE DIPSTICKS
K790805 · DIT
Technical Resources, Inc.
Toxicology · 42d
Cleared Jun 05, 1979
STRESS TESTING SYSTEM, MULTI-POSITION
K790544 · DRT
Engineering Dynamics Corp.
Cardiovascular · 75d
Cleared Jun 05, 1979
FETAL MATURITY TEST PROCEDURE
K790798 · JHG
Helena Laboratories
Chemistry · 49d
Cleared Jun 05, 1979
MEDI-TRACE EEG CREME
K790818 · GYB
Graphic Controls Corp.
Neurology · 39d
Cleared Jun 05, 1979
FORCEPS #101 AND #102
K790854 · GEN
C. Intl.
General & Plastic Surgery · 32d
Cleared Jun 05, 1979
AMALCAP-NON-GAMMA-2
K790874 · EJJ
Vivadent (Usa), Inc.
Dental · 29d
Cleared Jun 05, 1979
TEE ADAPTER
K790887 · BZA
Airlife, Inc.
Anesthesiology · 29d
Cleared Jun 05, 1979
TWO-WAY ANESTHESIA FILTER
K790896 · CAH
Pharmaseal Div., Baxter Healthcare Corp.
General Hospital · 28d
Cleared Jun 05, 1979
GORDON IVS INTRAVENOUS STABILIZER
K790946 · GBJ
Whitman Medical Corp.
General & Plastic Surgery · 18d
Cleared Jun 05, 1979
CLAMP COVERS
K790952 · GAD
Medi-Spec
General & Plastic Surgery · 14d
Cleared Jun 05, 1979
KIMLON IMPERVIOUS STOCKINETTES
K790972 · KKX
Kimberly-Clark Corp.
General Hospital · 14d
Cleared Jun 05, 1979
REYNOLDS DOUBLE HEMOCLIP APPLIERS
K790990 · GDO
Edward Weck, Inc.
General & Plastic Surgery · 6d
Cleared Jun 04, 1979
LEADS, IMPLANTABLE CARDIAC PACEMAKERS
K782018 · DTB
Oscor, Inc.
Cardiovascular · 181d
Cleared Jun 01, 1979
CAP, TAMPER PROOF PLASTIC
K782113 · KPE
Acacia, Inc.
General Hospital · 164d
Cleared Jun 01, 1979
AUTO TRAUMA KIT
K790411 · KME
Marshall Electronics, Inc.
General Hospital · 95d
Cleared Jun 01, 1979
QUICKSCAN HOLTER II
K790476 · DSH
Intl. Medical, Inc.
Cardiovascular · 88d
Cleared Jun 01, 1979
BROWNE MODEL UD-4DE
K790478 · FAP
Browne Corp.
Gastroenterology & Urology · 84d
Cleared Jun 01, 1979
ENDOCARDIAL PACING LEAD, MODEL 476-01
K790548 · DTB
Intermedics, Inc.
Cardiovascular · 73d
Cleared Jun 01, 1979
ALARM
K790559 · FRN
Maddak, Inc.
General Hospital · 74d
Cleared Jun 01, 1979
VITALITH S 3000 SERIES
K790666 · DXY
Vitatron Medical BV
Cardiovascular · 56d
Cleared Jun 01, 1979
TECNOL BODY HOLDER
K790699 · FMQ
Tecnol New Jersey Wound Care, Inc.
General Hospital · 50d
Cleared Jun 01, 1979
TOUCHLESS TM FOLEY CATHETER KIT
K790728 · KOD
Diamed Division Ill. Tool Works, Inc.
Gastroenterology & Urology · 49d
Cleared Jun 01, 1979
BROWNE MODEL CF-1 AND CF-1G
K790754 · FAP
Browne Corp.
Gastroenterology & Urology · 45d
Cleared Jun 01, 1979
LIFEPAK 5 MONITOR, CASSETTE, #800923-01
K790757 · DSH
Physio-Control Corp.
Cardiovascular · 45d