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
147961–147984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1985
SAHARA SUNBED
K852957 · FTC
Sahara Sun Beds., Inc.
General & Plastic Surgery · 17d
Cleared Jul 29, 1985
P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION
K852964 · DXQ
Howmedica Corp.
Cardiovascular · 17d
Cleared Jul 29, 1985
REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11
K852994 · CAL
Reichert-Jung, Inc.
Anesthesiology · 14d
Cleared Jul 29, 1985
SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420
K853015 · GEN
The Huxley Instrument Corp.
General & Plastic Surgery · 12d
Cleared Jul 26, 1985
STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN
K850214 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 185d
Cleared Jul 26, 1985
COMPUTE RX-PLAN
K850977 · KPQ
Medicalibration
Radiology · 140d
Cleared Jul 26, 1985
HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES
K851236 · FJK
Infarkem Corp.
Gastroenterology & Urology · 121d
Cleared Jul 26, 1985
VARICES INJECTOR
K851952 · FBK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Jul 26, 1985
DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY
K851973 · HAW
Diasonics, Inc.
Neurology · 80d
Cleared Jul 26, 1985
ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1
K852309 · FJK
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Jul 26, 1985
NATURALYTE BICARBONATE CONCENTRATE-DRY PACK
K852310 · FKQ
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Jul 26, 1985
TRICOT ADHESIVE BANDAGE
K852462 · KGX
American White Cross, Inc.
General & Plastic Surgery · 46d
Cleared Jul 26, 1985
TAYLOR PERCUSSION HAMMER SS 410 OR 420
K852716 · GWZ
The Huxley Instrument Corp.
Neurology · 30d
Cleared Jul 26, 1985
STERILE, DISPOSABLE NEEDLE
K852817 · GAA
Fabersanitas, S.A.
General & Plastic Surgery · 25d
Cleared Jul 26, 1985
4 X 4' GAUZE PAD
K852857 · EFQ
Cornelia Damsky, Inc.
General & Plastic Surgery · 21d
Cleared Jul 26, 1985
STRETCH BANDAGE
K852858
Cornelia Damsky, Inc.
General & Plastic Surgery · 21d
Cleared Jul 26, 1985
MEDILOG M3
K852883 · DSI
Oxford Medilog, Inc.
Cardiovascular · 17d
Cleared Jul 26, 1985
MEDILOG M1
K852884 · DSI
Oxford Medilog, Inc.
Cardiovascular · 17d
Cleared Jul 26, 1985
SPINAL FIXATION INSTRUMENTATION SYSTEM
K852891
Buckman Co., Inc.
General & Plastic Surgery · 17d
Cleared Jul 26, 1985
ESTERIPAPEL BAGS
K852904
Sophlaril Hispania, S. A.
General & Plastic Surgery · 17d
Cleared Jul 26, 1985
THE IVY POLE-INTRAVENOUS BOT TREES #1121K & 1221K
K852937 · FOX
Northern Customfab, Inc.
General Hospital · 16d
Cleared Jul 26, 1985
WINGED INFUSION SETS
K852989 · FPA
An-Med Intl.
General Hospital · 11d
Cleared Jul 25, 1985
MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER
K850898 · DRS
Medi-Trace Products Division
Cardiovascular · 143d
Cleared Jul 25, 1985
TUBULITEC LINER
K851053 · EJK
Dental Therapeutics AB
Dental · 133d