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
171865–171888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 26, 1978
RESPITRACE
K772016 · BZK
Respitrace Corp.
Anesthesiology · 93d
Cleared Jan 26, 1978
PRINTER
K772099 · JJJ
Miles Laboratories, Inc.
Chemistry · 80d
Cleared Jan 26, 1978
TELESCOPING BEDRAILS
K772260 · FNJ
Med Fusion Systems, Inc.
General Hospital · 48d
Cleared Jan 26, 1978
TRAPEZE FLOOR BASE
K772261 · FNJ
Med Fusion Systems, Inc.
General Hospital · 48d
Cleared Jan 26, 1978
TRAPEZE BAR KNOCKED DOWN
K772262 · FNJ
Med Fusion Systems, Inc.
General Hospital · 48d
Cleared Jan 26, 1978
FILTERSET W/Y-INJECTION SITE, 0.2
K772312 · FPB
Abbott Laboratories
General Hospital · 41d
Cleared Jan 26, 1978
DIALYZER STANDARD, CODE 5DM1780
K772318 · FJG
Travenol Laboratories, S.A.
Gastroenterology & Urology · 38d
Cleared Jan 26, 1978
GLOVE & LATEX FINGER COTS
K772336 · FMC
Jamar Health Products
General Hospital · 38d
Cleared Jan 26, 1978
SYRINGE, BLOOD, SAMPLING, ARTERIAL
K772338 · FMF
C.R. Bard, Inc.
Hematology · 35d
Cleared Jan 26, 1978
BLOOD LINE COMP. NEG. PRESS. PILLOW
K772355 · FIW
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Jan 26, 1978
THERMOMETER SHEATHS
K772365 · FLK
Medline Industries, Inc.
General Hospital · 30d
Cleared Jan 26, 1978
BAG, DRAINAGEW/ADHESIVE
K772366 · FON
Atlantic Surgical
Gastroenterology & Urology · 30d
Cleared Jan 26, 1978
QUADRIPLEGIC URINARY DRAINAGE VALVE
K772402 · FAQ
Fred Sammons, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 26, 1978
TUBING CLAMP
K772405 · FFN
Fred Sammons, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 26, 1978
HEEL OR ELBOW PROTECTOR
K772419 · FMP
Fred Sammons, Inc.
General Hospital · 30d
Cleared Jan 26, 1978
SPIRAFLOW DIALYZERS
K772423 · FJI
Bentley Laboratories, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 26, 1978
GENERATOR, OXYGEN, PORTABLE
K780020 · CAW
Jet Research Center, Inc.
Anesthesiology · 23d
Cleared Jan 26, 1978
ACCELERATOR, LINEAR, MED.
K780027 · IYE
Emi Therapy Systems, Inc.
Radiology · 22d
Cleared Jan 26, 1978
SPECIMEN COLLECTION DEVICE
K780049 · FMH
Urol, Inc.
General Hospital · 17d
Cleared Jan 26, 1978
TAMPON, HEAVY DUTY, & STICK
K780058 · HIL
Kimberly-Clark Corp.
Obstetrics & Gynecology · 14d
Cleared Jan 26, 1978
CAMERA, GAMMA
K780060 · IYX
Ackerman-Schmehl Industries, Inc.
Radiology · 15d
Cleared Jan 24, 1978
MINIMAP MODEL 810
K771981 · DSK
Applied Medical Research
Cardiovascular · 98d
Cleared Jan 24, 1978
LAS-R HUMAN C3 PROACTIVATOR TEST
K772084 · JZH
Hyland Therapeutic Div., Travenol...
Immunology · 81d
Cleared Jan 24, 1978
LAS-R HUMAN PLASMINOGEN TEST
K772085 · DDX
Hyland Therapeutic Div., Travenol...
Immunology · 81d