FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
162409–162432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 16, 1981
KF-E SERIES OF HOLLOW FIBER DIALYZERS
K812353 · FJI
Medisystems Corp.
Gastroenterology & Urology · 28d
Cleared Sep 16, 1981
MEDTRONIC #3798 ELECTRODE
K812418 · GXY
Medtronic Vascular
Neurology · 23d
Cleared Sep 16, 1981
3M INFUSION SYSTEM
K812442 · FRN
3M Company
General Hospital · 20d
Cleared Sep 16, 1981
INFUSION PUMP
K812499 · FRN
Nu Tech Medical Systems
General Hospital · 16d
Cleared Sep 16, 1981
PALL ULTIPOR VACUUM LINE BACTERIA FITLER
K812505 · JQC
Pall Biomedical Products Co.
Chemistry · 15d
Cleared Sep 16, 1981
TRAVENOL INFUSION CONTROLLER 2M8052
K812510 · LDR
Travenol Laboratories, S.A.
General Hospital · 14d
Cleared Sep 16, 1981
MICRO BLADE II
K812526 · GES
Vxtra Corp.
General & Plastic Surgery · 14d
Cleared Sep 16, 1981
IVA SEAL II
K812527 · KPE
U.S. Clinical Products, Inc.
General Hospital · 14d
Cleared Sep 14, 1981
NON-MEASURING EXERCISERS
K812351 · ION
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Sep 14, 1981
HYGIENE ADAPTORS
K812352 · ILS
Fred Sammons, Inc.
Physical Medicine · 27d
Cleared Sep 14, 1981
CHAIR, ADJUSTABLE, MECHANICAL
K812399 · INN
Kaye Products, Inc.
Physical Medicine · 25d
Cleared Sep 14, 1981
CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O
K812401 · IPT
Surgical Appliance Industries, Inc.
Physical Medicine · 25d
Cleared Sep 14, 1981
KALLESTAD 125I ANTISERUM TO HUMAN IGE
K812414 · DHB
Kallestad Laboratories, Inc.
Chemistry · 24d
Cleared Sep 14, 1981
CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS
K812422 · IPY
Surgical Appliance Industries, Inc.
Physical Medicine · 21d
Cleared Sep 14, 1981
NEOPRENE KNEE SUPPORT
K812423 · ITQ
Surgical Appliance Industries, Inc.
Physical Medicine · 21d
Cleared Sep 14, 1981
PHOS MICROTUBES
K812465 · JSF
Carr Microbiologicals
Microbiology · 14d
Cleared Sep 14, 1981
ONPX-INDOL MEDIUM MICROTUBES
K812466 · JSE
Carr Microbiologicals
Microbiology · 14d
Cleared Sep 14, 1981
PGUA-INDOL MICROTUBE
K812467 · JSE
Carr Microbiologicals
Microbiology · 14d
Cleared Sep 14, 1981
PYRR MICROTUBE
K812468 · JSF
Carr Microbiologicals
Microbiology · 14d
Cleared Sep 14, 1981
RAPID DECARBOXYLASE/DIHYDROLASE MICROTUB
K812469 · JSF
Carr Microbiologicals
Microbiology · 14d
Cleared Sep 14, 1981
HIPP MICROTUBE
K812470 · JSF
Carr Microbiologicals
Microbiology · 14d
Cleared Sep 14, 1981
SPIN-CHEM TRIGLYCERIDES REAGENT
K812471 · CDT
Smithkline Diagnostics, Inc.
Chemistry · 14d
Cleared Sep 14, 1981
SPIN-CHEM LD-L REAGENT
K812472 · CFJ
Smithkline Diagnostics, Inc.
Chemistry · 14d
Cleared Sep 14, 1981
BABY WALKER W/TOY CHEST
K812474 · ION
Maddak, Inc.
Physical Medicine · 14d