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
153289–153312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 1984
ACME DIGITAL INFANT SCALE-30
K841534 · FRW
Acme Medical Scale Co.
General Hospital · 45d
Cleared May 31, 1984
IMPACT MODEL 601
K841537 · BTI
Impact Instrumentation, Inc.
Anesthesiology · 45d
Cleared May 31, 1984
CHOCOLATE AGAR
K841586 · KZI
Microline Scientific
Microbiology · 44d
Cleared May 31, 1984
HEALTHCHECK HOME PREGNANCY TEST KIT
K841595 · LCX
Timex Medical Products Corp.
Chemistry · 43d
Cleared May 31, 1984
TDX REA URIC ACID
K841702 · KNK
Abbott Laboratories
Chemistry · 38d
Cleared May 31, 1984
KYOTEST UG URINE TEST REAGENT STRIP
K841713 · JIL
Kyoto Diagnostics, Inc.
Chemistry · 37d
Cleared May 31, 1984
KYOTEST 2V, URINE TEST REAGENT STRIP
K841714 · JIL
Kyoto Diagnostics, Inc.
Chemistry · 37d
Cleared May 31, 1984
KYOTEST UK URINE TEST REAGENT STRIP
K841715 · JIN
Kyoto Diagnostics, Inc.
Chemistry · 37d
Cleared May 31, 1984
SALMONELLA-SHIGELLA AGAR
K841746 · JSJ
The Montana Deaconess Medical Center
Microbiology · 34d
Cleared May 31, 1984
SHEEP BLOOD AGAR
K841748 · KZI
The Montana Deaconess Medical Center
Microbiology · 34d
Cleared May 31, 1984
CHOCOLATE AGAR
K841749 · KZI
The Montana Deaconess Medical Center
Microbiology · 34d
Cleared May 31, 1984
MARTIN-LEWIS AGAR
K841750 · JTY
The Montana Deaconess Medical Center
Microbiology · 34d
Cleared May 31, 1984
LEVINE EOSIN METHYLENE BLUE AGAR
K841751 · JSI
The Montana Deaconess Medical Center
Microbiology · 34d
Cleared May 31, 1984
CYANOMETHEMOGLOBIN REAGENT
K841799 · GIF
Reagent Laboratory, Inc.
Hematology · 43d
Cleared May 31, 1984
LYSING & HEMOGLOBIN REAGENT
K841800 · GGK
Reagent Laboratory, Inc.
Hematology · 43d
Cleared May 31, 1984
ELVI 70 SAFETY CHAMBER
K841804 · JJN
Logos Scientific, Inc.
Chemistry · 30d
Cleared May 31, 1984
DIFFERENTIAL CULTURE MED. MACCONKEY AGAR
K841842 · JSI
Microline Scientific
Microbiology · 44d
Cleared May 31, 1984
DIFFERENTIAL CULTURE MED. LEVINE EMB
K841843 · JSH
Microline Scientific
Microbiology · 44d
Cleared May 31, 1984
DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR
K841844 · JSI
Microline Scientific
Microbiology · 44d
Cleared May 31, 1984
SELECTIVE CULTURE MED. COLUMBIA CNA
K841845 · JSJ
Microline Scientific
Microbiology · 44d
Cleared May 31, 1984
RETIC-SET
K841848 · KQC
R&D Systems, Inc.
Hematology · 64d
Cleared May 31, 1984
INNOFLOUR GENTAMICIN
K841865 · LCQ
Innotron Diagnostics
Toxicology · 27d
Cleared May 31, 1984
INNOFLOUR TOBRAMYCIN
K841866 · LFW
Innotron Diagnostics
Toxicology · 27d
Cleared May 31, 1984
MEGA PULSE THERAPY UNIT
K841874 · IMJ
Physio Technology, Inc.
Physical Medicine · 24d