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
105841–105864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1994
ROBO
K942508 · INI
Permobil AB
Physical Medicine · 165d
Cleared Nov 07, 1994
B-D GUARDIAN NESTABLE SHARPS COLLECTORS
K943134 · FMI
Med-Safe Systems, Inc.
General Hospital · 131d
Cleared Nov 07, 1994
MED-SAFE INSULIN SHARPS CONTAINER
K943135 · FMI
Med-Safe Systems, Inc.
General Hospital · 131d
Cleared Nov 07, 1994
B-D GUARDIAN POINT-OF-USE VERTICAL ENTRY SHARPS COLLECTORS
K943136 · FMI
Med-Safe Systems, Inc.
General Hospital · 131d
Cleared Nov 07, 1994
B-D/BFI MAIL DISPOSAL SERVICE
K943137 · FMI
Med-Safe Systems, Inc.
General Hospital · 131d
Cleared Nov 07, 1994
B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS
K943140 · FMI
Med-Safe Systems, Inc.
General Hospital · 131d
Cleared Nov 07, 1994
B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS
K943141 · FMI
Med-Safe Systems, Inc.
General Hospital · 131d
Cleared Nov 07, 1994
CONMED SELECTONE MINIMAL ACCESS SURGERY INSTRUMENTS
K943327 · GCJ
Conmedcorp
General & Plastic Surgery · 118d
Cleared Nov 07, 1994
GEMNET
K943355 · IZI
GE Medical Systems
Radiology · 118d
Cleared Nov 07, 1994
CHOLANGIOGRAPHY SET
K943435 · GCJ
Karl Storz Endoskop GmbH
General & Plastic Surgery · 112d
Cleared Nov 07, 1994
LIMITED REUSE BLADES
K943985 · HRX
Linvatec Corp.
Orthopedic · 83d
Cleared Nov 07, 1994
SPECTRUM DISIGNS PECTORAL IMPLANT
K944163 · MIC
Spectrum Designs, Inc.
General & Plastic Surgery · 73d
Cleared Nov 07, 1994
SINUSCOPE
K944186 · EOB
Stryker Endoscopy
Ear, Nose, Throat · 73d
Cleared Nov 07, 1994
DIAL MEDICAL SUPPLY SHARPS CONTAINER
K944230 · FMI
Regulatory & Marketing Services, Inc.
General Hospital · 68d
Cleared Nov 07, 1994
PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP
K944552 · FZP
Pilling Weck, Inc.
General & Plastic Surgery · 52d
Cleared Nov 07, 1994
STERILE PLASTIC DRESSING
K944588 · KGX
Smith & Nephew, Inc.
General & Plastic Surgery · 49d
Cleared Nov 07, 1994
JEL 96
K944679 · EJT
J.F. Jelenko & Co., Inc.
Dental · 46d
Cleared Nov 07, 1994
EUREKA PLUS
K944887 · EJT
J.F. Jelenko & Co., Inc.
Dental · 34d
Cleared Nov 07, 1994
MEDALIST
K944888 · EJT
J.F. Jelenko & Co., Inc.
Dental · 34d
Cleared Nov 07, 1994
CELEBRITY XL SC445
K944939 · INI
Pride Health Care, Inc.
Physical Medicine · 31d
Cleared Nov 07, 1994
OPTUS LARYNGOSCOPES
K945269 · CCW
Optus, Inc.
Anesthesiology · 10d
Cleared Nov 04, 1994
SALINE FOR IRRIGATION
K932138 · JOL
Rantran, Inc.
General Hospital · 562d
Cleared Nov 04, 1994
SIGMA GLUCOSE REAGENT
K933694 · CGA
Sigma Chemical Co.
Chemistry · 463d
Cleared Nov 04, 1994
HARD TISSUE REPLACEMENT (HTR) GRANULAR
K934861 · KKY
Poly-Medics,Inc.
General & Plastic Surgery · 388d