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
139153–139176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1987
VISION(R) TOTAL BILIRUBIN
K872487 · CIG
Abbott Laboratories
Chemistry · 59d
Cleared Aug 21, 1987
EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95
K872512 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Aug 21, 1987
EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604
K872513 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Aug 21, 1987
INNOTRON INNOFLUOR PHEYTOIN REAGENT SET
K872563 · LGR
Innotron of Oregon, Inc.
Chemistry · 58d
Cleared Aug 21, 1987
THE PORTABLE ORDERLY
K872900 · FWZ
Edgewater Medical Equipment Systems
General & Plastic Surgery · 28d
Cleared Aug 21, 1987
BIOTROL CHOLESTEROL ENZYMATIQUE COLOR
K872930 · CHH
Biotrol, USA, Inc.
Chemistry · 25d
Cleared Aug 21, 1987
POREX QUALITY PLASTIC SURGERY INSTRUMENTS
K872947 · KDG
Porex Medical
General & Plastic Surgery · 24d
Cleared Aug 21, 1987
DELFIA(TM) FERRITIN KIT
K872955 · JMG
Lkb Instruments, Inc.
Microbiology · 23d
Cleared Aug 21, 1987
MICRINS NEEDLE HOLDER
K872989 · HXK
Micrins Surgical, Inc.
Orthopedic · 21d
Cleared Aug 21, 1987
RPMI-1640 MEDIUM (HAT MODIFIED) NO. 200-2080
K873084 · KIT
J R Scientific
Pathology · 15d
Cleared Aug 21, 1987
WAYMOUTH 752/1 MEDIUM (MODIFIED) NO. 200-2085
K873085 · KIT
J R Scientific
Pathology · 15d
Cleared Aug 21, 1987
INSTANT HEMATOXYLIN
K873107 · HYK
Shandon, Inc.
Pathology · 14d
Cleared Aug 19, 1987
SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007
K854654 · IYO
Philips Medical Systems, Inc.
Radiology · 638d
Cleared Aug 19, 1987
TOTAL BILIRUBIN REAGENT - DMSO METHOD
K870364 · CIG
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD
K870365 · CIG
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
CREATININE REAGENT - PICRIC ACID METHOD
K870366 · CGX
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION
K870368 · CEO
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
CALCIUM REAGENT-METHYL THYMOL BLUE METHOD
K870369 · CIA
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
MAGNESIUM REAGENT - CALMAGITE METHOD
K870370 · JGJ
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
TOTAL PROTEIN REAGENT - BIURET METHOD
K870371 · CEK
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
ALBUMIN REAGENT - BROMCRESOL GREEN METHOD
K870372 · CIX
Trace Scientific , Ltd.
Chemistry · 203d
Cleared Aug 19, 1987
LATEX R. CONORII
K872129 · LSQ
Health Research, Inc.
Microbiology · 78d
Cleared Aug 19, 1987
VIVID CHLAMYDIA(TM)
K872148 · LJC
Seragen Diagnostics, Inc.
Microbiology · 76d
Cleared Aug 19, 1987
LB 9502 - CLINILUMAT, LB 952 - AUTO-CLINILUMAT
K872324 · JJQ
Berthold Analytical Instruments, Inc.
Chemistry · 63d