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
168265–168288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 11, 1979
ACU-ALERT
K791399
Acumed Instruments Corp.
Cardiovascular · 87d
Cleared Oct 11, 1979
MODEL 80-1765 ELECTROSURGICAL UNIT
K791415 · GEI
Cameron-Miller, Inc.
General & Plastic Surgery · 72d
Cleared Oct 11, 1979
TECHNICON FAST-LC SYS. FOR THEOPHYLLINE
K791431 · DPA
Technicon Instruments Corp.
Toxicology · 77d
Cleared Oct 11, 1979
ADAMCO DUST COVER
K791513 · FRG
Chase Mfg. Co.
General Hospital · 76d
Cleared Oct 11, 1979
TETRAHYDROCANNALBINOL DIRECT BLOOD KIT
K791649 · LAT
Immunalysis Corporation
Toxicology · 48d
Cleared Oct 11, 1979
MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL
K791659 · HQF
Coburn Optical Ind., Inc.
Radiology · 50d
Cleared Oct 11, 1979
CDC ANAEROBIC BLOOD AGAR PHENETHYLAL
K791697 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 44d
Cleared Oct 11, 1979
COUNTER-CHECK PLUS
K791750 · JPK
Diagnostic Technology, Inc.
Hematology · 36d
Cleared Oct 11, 1979
BOVIE CSV HAND CONTROL ADAPTER
K791767 · GEI
Sybron Corp.
General & Plastic Surgery · 36d
Cleared Oct 11, 1979
COUNTER-CHECK PLUS NORMAL, HIGH ABN.
K791772 · JPK
Diagnostic Technology, Inc.
Hematology · 34d
Cleared Oct 11, 1979
ORTHO ANTIBODY ENHANCEMENT SOLUTION
K791791 · KSG
Ortho Diagnostics, Inc.
Hematology · 30d
Cleared Oct 11, 1979
MTS CATHETER ADAPTER FOR GUIDANCE ENTRY
K791797 · DTL
Medical Testing System, Inc.
Cardiovascular · 27d
Cleared Oct 11, 1979
M015 OXYGEN & MA15 AIR
K791900 · CAX
Timeter Instrument Corp.
Anesthesiology · 16d
Cleared Oct 11, 1979
3-WAY STOPCOCK W/MALE LOCKING LUER ADA.
K791914 · DTL
Abbott Laboratories
Cardiovascular · 16d
Cleared Oct 11, 1979
WRIGHTS RAPID STAIN
K791929 · IAF
Mcb Manufacturing Chemists, Inc.
Hematology · 14d
Cleared Oct 11, 1979
SERACON CAL D025
K791956 · JIX
Bhp Diagnostix, Inc.
Chemistry · 10d
Cleared Oct 11, 1979
SERACON -LO DO26
K791957 · JJX
Bhp Diagnostix, Inc.
Chemistry · 10d
Cleared Oct 11, 1979
MODEL 15055A MAINFRAME
K791964 · DRR
Hewlett-Packard Co.
Cardiovascular · 10d
Cleared Oct 11, 1979
ARGYLE PEDIATRIC VENA CAVAL CATHETER
K791972 · DWF
Sherwood Medical Co.
Cardiovascular · 9d
Cleared Oct 10, 1979
BILSOM PROPP
K791608 · EWD
Bilson International, Inc.
Ear, Nose, Throat · 58d
Cleared Oct 09, 1979
DUO TWO LAYER DENTURE CLEANSER
K791064 · EFT
Block Drug Company, Inc.
Dental · 120d
Cleared Oct 09, 1979
THERMAL CONDITIONING SYSTEM
K791154 · IRT
Acurex Aerotherm
Physical Medicine · 111d
Cleared Oct 09, 1979
DEN-MAT DENTAL FLOSSER
K791223 · JES
Den-Mat Corp.
Dental · 98d
Cleared Oct 09, 1979
ORATRONICS ENDOSSEOUS FRAME ASSEMBLY
K791366 · NRQ
Oratronics, Inc.
Dental · 76d