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
161137–161160 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 12, 1982
SIMUL-FER SERUM IRON TEST KIT
K820253 · JJA
Diagnostic Reagents, Inc.
Chemistry · 103d
Cleared May 12, 1982
MEZLIN DIAGNOSTIC REAGENT
K820578 · JTT
Miles Pharmaceuticals
Microbiology · 70d
Cleared May 12, 1982
GAMMA FETAL BLEED SCREENING TEST
K820647 · LIM
Gamma Biologicals, Inc.
Hematology · 64d
Cleared May 12, 1982
THE ICR KNEE
K820719
American Ortomed Corp.
Orthopedic · 57d
Cleared May 12, 1982
HEMATALL-C PLUS HEMATOLOGY CONTROLS
K820731 · JPK
Fisher Scientific Co., LLC
Hematology · 56d
Cleared May 12, 1982
FETAL-TEK CONTROL (IMMATURE/BORDERLINE)
K820772 · JJX
Helena Laboratories
Chemistry · 50d
Cleared May 12, 1982
MINI-MICRO ARTHROSCOPIC SCAPEL
K820777 · HRX
The Anspach Effort, Inc.
Orthopedic · 50d
Cleared May 12, 1982
CURITY PREMIUM CYSTOSCOPY TRAY
K820850 · KKX
The Kendal Co.
General Hospital · 47d
Cleared May 12, 1982
HI-PHORE HIGH RESOLUTION ELECTROPHORES
K821303 · JJN
Gelman Sciences, Inc.
Chemistry · 8d
Cleared May 11, 1982
CURITY ECONOMY I CYSTOSCOPY
K820838 · KOD
The Kendal Co.
Gastroenterology & Urology · 46d
Cleared May 10, 1982
RESILIENT GUM EXERCISER
K820979 · JET
Martin A. Hass, D.D.S.
Dental · 34d
Cleared May 10, 1982
PRECIOUS METAL ALLOYS
K821022 · EJS
J. Aderer, Inc.
Dental · 27d
Cleared May 10, 1982
BLINK-N-CLEAN
K821055 · HPX
Allergan, Inc.
Ophthalmic · 25d
Cleared May 10, 1982
ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG
K821079 · KLX
Ms. Kate Teaney
Ear, Nose, Throat · 21d
Cleared May 10, 1982
PEDIATRIC URINE COLLECTOR
K821130
Abco Dealers, Inc.
Gastroenterology & Urology · 20d
Cleared May 10, 1982
TS-180 SERIES TUBING SET
K821138 · FJK
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 19d
Cleared May 10, 1982
SPS-SINGLE PATIENT SYSTEM
K821139 · FIR
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 19d
Cleared May 10, 1982
EXTERNAL URINARY MALE INCONTINENCE DEV
K821161 · KNX
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared May 10, 1982
URINARY COLLECTION CONTAINER/LEG BAG
K821171 · KNX
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared May 10, 1982
EXTERNAL FEMALE URINARY INCONTINENCE
K821172 · KNX
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared May 10, 1982
VIVONEX TUNGSTEN TIP TUBE PLACEMENT
K821231 · KNT
Norwich Eaton Pharmaceuticals, Inc.
Gastroenterology & Urology · 13d
Cleared May 10, 1982
TECHNICON RA-1000 SYS, ANALYTES III
K821514 · JEJ
Technicon Instruments Corp.
Chemistry
Cleared May 07, 1982
MULTI-UNIT, MULTI-PURPOSE DEVICE
K813638 · EFS
The Scott & Fetzer Co.
Dental · 128d
Cleared May 07, 1982
INTRA-ARTICULAR SURGICAL SYSTEM
K820367 · KIJ
Dyonics, Inc.
Orthopedic · 87d