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
137521–137544 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 1988
LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II
K874280 · JJY
Bio-Rad
Chemistry · 93d
Cleared Jan 21, 1988
SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM
K874284 · JHT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 99d
Cleared Jan 21, 1988
STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY
K874438 · LEH
Baxter Healthcare Corp
Chemistry · 85d
Cleared Jan 21, 1988
KODAK EKTACHEM DT SLIDES (MG)
K874576 · JGJ
Eastman Kodak Company
Chemistry · 76d
Cleared Jan 21, 1988
KODAK EKTACHEM DT SLIDES (PHOS)
K874577 · CEO
Eastman Kodak Company
Chemistry · 76d
Cleared Jan 21, 1988
TRIGLYERIDES TEST KIT
K874584 · CDT
Ciba Corning Diagnostics Corp.
Chemistry · 73d
Cleared Jan 21, 1988
EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017
K874586 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Jan 21, 1988
MULTICHEM (R) MAGNESIUM REAGENT
K874595 · JGJ
Simmler, Inc.
Immunology · 73d
Cleared Jan 21, 1988
EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010
K874600 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 73d
Cleared Jan 21, 1988
ADEL MODEL 2100 BIRTHING BED
K874610 · HDD
Adel Medical , Ltd.
Obstetrics & Gynecology · 73d
Cleared Jan 21, 1988
V-TREND BETA-HCG TEST
K874638 · JHJ
Texas Immunology, Inc.
Immunology · 70d
Cleared Jan 21, 1988
RAICHEM(TM) MAGNESIUM REAGENT
K874822 · JGJ
Reagents Applications, Inc.
Chemistry · 58d
Cleared Jan 21, 1988
CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY
K874824 · DII
Supelco, Inc.
Toxicology · 58d
Cleared Jan 21, 1988
PYRIDOXAL-5-PHOSPHATE TABLETS
K874835 · CKA
Boehringer Mannheim Corp.
Chemistry · 58d
Cleared Jan 21, 1988
XL-4 PAGODA (CONDOMS)
K874851 · HIS
Mayer Laboratories
Obstetrics & Gynecology · 57d
Cleared Jan 21, 1988
QUANTIMETRIX URINE DIPSTICK CONTROL
K874890 · JJW
Quantimetrix Medical Industries
Chemistry · 51d
Cleared Jan 20, 1988
IVY COMMANDER (MODEL 500)
K870820 · LDR
Ivy Medical, Inc.
General Hospital · 323d
Cleared Jan 20, 1988
LEE COMPOSITE INLAY SYSTEM
K873123 · EBF
Lee Pharmaceuticals
Dental · 163d
Cleared Jan 20, 1988
VAN DELLEN BACTERIA FILTER
K873465 · FPK
Van Dellen, Ltd.
General Hospital · 145d
Cleared Jan 20, 1988
LASER LAPAROSCOPY SET
K873598 · HET
Cuda Products Co.
Obstetrics & Gynecology · 138d
Cleared Jan 20, 1988
AGC UNICOMPARTMENTAL KNEE PROSTHESIS
K873601 · HRY
Biomet, Inc.
Orthopedic · 149d
Cleared Jan 20, 1988
ACE INTRA COMPARTMENTAL PRESSURE MONITOR
K873684 · LXC
Ace Medical Co.
Orthopedic · 128d
Cleared Jan 20, 1988
SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY
K874665 · LRP
Precision Dynamics Corp.
General & Plastic Surgery · 68d
Cleared Jan 20, 1988
VITALON MASSAGER
K874843 · ISA
Nexus Co. , Ltd. C/O Yama Trans Co. ,...
Physical Medicine · 57d