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
160009–160032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 1982
OLSEN HEGAR NEEDLE HOLDERS
K821295 · GDF
Conphar, Inc.
General & Plastic Surgery · 30d
Cleared Jun 03, 1982
IOI METAL BACKED TIBIAL COMPONENT
K821341 · HRY
Intermedics Orthopedics
Orthopedic · 29d
Cleared Jun 03, 1982
BDH FEMORAL COMPONENT
K821343 · KWL
Intermedics Orthopedics
Orthopedic · 29d
Cleared Jun 03, 1982
CONPHAR MAYO HEGAR NEEDLE HOLDER
K821354 · GDF
Conphar, Inc.
General & Plastic Surgery · 29d
Cleared Jun 03, 1982
SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER
K821394 · MMK
Kleen Test Products
General Hospital · 23d
Cleared Jun 03, 1982
SADDLEBAG INSTRUMENT PAD W/POUCHES
K821395
Kleen Test Products
General Hospital · 23d
Cleared Jun 03, 1982
ULTRACHEM CREA #64972
K821472
Emd Chemicals, Inc.
Chemistry · 16d
Cleared Jun 03, 1982
ULTRAZYME PLUS CKI, #64978,65027&65028
K821473 · CGS
Emd Chemicals, Inc.
Chemistry · 16d
Cleared Jun 03, 1982
ULTRACHEM URIC ACID AIDH #65047
K821474 · CDO
Emd Chemicals, Inc.
Chemistry · 16d
Cleared Jun 03, 1982
RIA STAT 16
K821494 · JJJ
E. R. Squibb & Sons, Inc.
Chemistry · 16d
Cleared Jun 03, 1982
IRIS URINE STAIN
K821503 · ICF
Intl. Remote Imaging Systems
Pathology · 15d
Cleared Jun 03, 1982
VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA
K821542 · LCR
Electro-Nucleonics Laboratories, Inc.
Toxicology · 10d
Cleared Jun 03, 1982
IPA FOR DETECTION OF PHENOBARBITAL
K821543 · LFN
Electro-Nucleonics Laboratories, Inc.
Toxicology · 10d
Cleared Jun 03, 1982
ORTHOPEDIC FIXATION DEVICES
K821566 · KTW
Howmedica Corp.
Orthopedic · 9d
Cleared Jun 03, 1982
PNEUMO PULSSOR III
K821570 · BYI
Strom Corp.
Anesthesiology · 7d
Cleared Jun 02, 1982
UNIFLEX
K820470 · NAB
Howmedica Corp.
General & Plastic Surgery · 100d
Cleared Jun 02, 1982
SURGIKOS INCISE DRAPE
K820542 · KKX
Surgikos, Inc.
General Hospital · 92d
Cleared Jun 02, 1982
RADIOIMMUNOASSAY PARATHYROID HORMONE MID
K821131 · CEW
Endocrine-Metabolic Center
Chemistry · 43d
Cleared Jun 02, 1982
INTERPULSE MEMBRANE OXYGENATOR
K821216 · DTZ
Extracorporeal Medical Specialities,...
Cardiovascular · 36d
Cleared Jun 02, 1982
#2010 CAMPHYLOBACTER AGAR
K821300 · JSI
Biomedia, Inc.
Microbiology · 29d
Cleared Jun 02, 1982
RETIC SET
K821318 · KJN
R&D Systems, Inc.
Hematology · 29d
Cleared Jun 02, 1982
HEMATOXYLIN STAIN
K821320 · HYJ
Sigma Chemical Co.
Pathology · 29d
Cleared Jun 02, 1982
ATRIAL J TEMPORARY PACING ELECTRODESS
K821333 · LDF
Medics Instrument Corp.
Cardiovascular · 28d
Cleared Jun 02, 1982
GLYCO-GEL TEST KIT
K821360 · LCP
Pierce Chemical Co.
Hematology · 26d