FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134737–134760 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 1988
RAICHEM(TM) BILIRUBIN STANDARD
K882726 · JIS
Reagents Applications, Inc.
Chemistry · 59d
Cleared Aug 29, 1988
DADE(R) CK-MB IMMUNOASSAY CONTROL
K882795 · JJT
Baxter Healthcare Corp
Chemistry · 54d
Cleared Aug 29, 1988
RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.
K882801 · JGS
Hf Scientific, Inc.
Chemistry · 53d
Cleared Aug 29, 1988
MEDIPAC II EC (TM), MODEL 7900
K882820 · GZJ
Medical Devices, Inc.
Neurology · 52d
Cleared Aug 29, 1988
SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN
K882909 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Aug 29, 1988
EMIT QST CARBAMAZEPINE ASSAY
K882961 · KLT
Syva Co.
Toxicology · 46d
Cleared Aug 29, 1988
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
K883115 · GWM
Pmt Corp.
Neurology · 35d
Cleared Aug 29, 1988
L-15 MEDIUM, CATALOG NO. 200-2021
K883362 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105
K883363 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.210-3505
K883364 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
HORSE SERUM, ABATTOIR, NO. 110-1112
K883365 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
MEDIUM 199, CATALOG NO. 200-2031
K883366 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
CALF SERUM, CATALOG NO. 110-1125
K883367 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
NEWBORN CALF SERUM, CATALOG NO. 110-1130
K883368 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
L-15 MEDIUM, CATALOG NO. 210-4004
K883369 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
FISCHER'S MEDIUM CATALOG NO. 210-4007
K883370 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-3012
K883445 · KIT
J R Scientific
Pathology · 14d
Cleared Aug 29, 1988
FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-1122
K883446 · KIT
J R Scientific
Pathology · 14d
Cleared Aug 29, 1988
MINIMUM ESSENTIAL MEDIUM EAGLE 10X, NO.210-3511
K883447 · KIT
J R Scientific
Pathology · 14d
Cleared Aug 29, 1988
MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-2046
K883448 · KIT
J R Scientific
Pathology · 14d
Cleared Aug 29, 1988
MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2048
K883449 · KIT
J R Scientific
Pathology · 14d
Cleared Aug 29, 1988
SFRE 199-2 MEDIUM, CATALOG NO. 200-2192
K883450 · KIT
J R Scientific
Pathology · 14d
Cleared Aug 29, 1988
MEDIUM 199, 10X, CATALOG NO. 210-3555
K883495 · KIT
J R Scientific
Pathology · 13d
Cleared Aug 29, 1988
MINIMUM ESSENTIAL MEDIUM EAGLE (MEM), 210-3517
K883496 · KIT
J R Scientific
Pathology · 13d