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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
98569–98592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1996
NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
K955657 · BYP
North State Plastics, Inc.
Anesthesiology · 91d
Cleared Mar 12, 1996
RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
K955679 · HIO
Contour Fabricators of Florida, Inc.
Obstetrics & Gynecology · 89d
Cleared Mar 12, 1996
KC 1A COAGULATION ANALYZER/SET
K955724 · JPA
Sigma Diagnostics, Inc.
Hematology · 85d
Cleared Mar 12, 1996
TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET
K955785 · DYB
C.R. Bard, Inc.
Cardiovascular · 82d
Cleared Mar 12, 1996
SYSCON TURMOR MARKER CONTROL
K955812 · JJY
Scantibodies Laboratory, Inc.
Chemistry · 77d
Cleared Mar 12, 1996
VOLMED OPERATION DRAPE
K955872 · KKX
Medal Intl. Sales Co., LLC
General Hospital · 75d
Cleared Mar 12, 1996
TOTAL PROTEIN REAGENT
K955936 · CEK
Derma Media Lab., Inc.
Chemistry · 82d
Cleared Mar 12, 1996
INORGANIC PHOSPHORUS REAGENT
K955937 · CEO
Derma Media Lab., Inc.
Chemistry · 82d
Cleared Mar 12, 1996
CREATININE REAGENT
K955938 · CGX
Derma Media Lab., Inc.
Chemistry · 82d
Cleared Mar 12, 1996
HIGH VOLUME I.V. & IRRIGATION TOWER
K960027 · FOX
Allen Medical Systems, Inc.
General Hospital · 70d
Cleared Mar 12, 1996
RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241
K960052 · ESD
Resound Corp.
Ear, Nose, Throat · 68d
Cleared Mar 12, 1996
BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE
K960081 · FCQ
Mitsubishi Cable America, Inc.
Gastroenterology & Urology · 61d
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM
K960129 · GRM
Sa Scientific, Inc.
Microbiology · 61d
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM
K960130 · GRM
Sa Scientific, Inc.
Microbiology · 61d
Cleared Mar 12, 1996
SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM
K960147 · GRM
Sa Scientific, Inc.
Microbiology · 61d
Cleared Mar 12, 1996
SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM
K960160 · GRM
Sa Scientific, Inc.
Microbiology · 61d
Cleared Mar 12, 1996
DIGISCOPE RX-2
K960198 · OXO
Medirex, Inc.
Radiology · 56d
Cleared Mar 12, 1996
CPR EYE TRAY
K960242 · KKX
Custom Pack Reliability
General Hospital · 56d
Cleared Mar 12, 1996
HEMAGEN CRP 150 KIT (EIA METHOD)
K960324 · DCK
Hemagen Diagnostics, Inc.
Immunology · 49d
Cleared Mar 12, 1996
DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE...
K960400 · FBM
Snowden-Pencer
Gastroenterology & Urology · 43d
Cleared Mar 12, 1996
SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM
K960461 · GRM
Sa Scientific, Inc.
Microbiology · 42d
Cleared Mar 12, 1996
SUNGLASSES/EYEGLASS FRAMES
K960573 · HQY
Architectures
Ophthalmic · 29d
Cleared Mar 12, 1996
BEAUCOUP GENERAL PURPOSE DISINFECTANT
K960580 · LRJ
Huntington Laboratories, Inc.
General Hospital · 29d
Cleared Mar 12, 1996
ASCEND GENERAL PURPOSE DISINFECTANT
K960582 · LRJ
Huntington Laboratories, Inc.
General Hospital · 29d