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
132361–132384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 08, 1989
DERMASTRIP
K883660 · KGX
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 166d
Cleared Feb 08, 1989
MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS)
K883661 · LWJ
Depuy, Inc.
Orthopedic · 166d
Cleared Feb 08, 1989
REPLICARE (ADDITIONAL CLAIMS)
K883849 · NAD
United Medical
General & Plastic Surgery · 149d
Cleared Feb 08, 1989
LAKE N/G FEEDING TUBE
K884127 · KNT
Lake Medical Products, Inc.
Gastroenterology & Urology · 131d
Cleared Feb 08, 1989
(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM
K884723 · KQX
Greenleaf Medical Systems, Inc.
Neurology · 90d
Cleared Feb 08, 1989
NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI
K884789 · KWL
Protek, Inc.
Orthopedic · 85d
Cleared Feb 08, 1989
LUMED EXPANDO-CATH, ACTIV
K884806 · FOZ
Luther Medical Products, Inc.
General Hospital · 83d
Cleared Feb 08, 1989
INTERA SHIELD AND INTERA UNDERGARMENT
K885185 · EYQ
Intera Corp.
Gastroenterology & Urology · 56d
Cleared Feb 08, 1989
AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT
K885195 · CDP
Amersham Corp.
Chemistry · 54d
Cleared Feb 08, 1989
FLUID DRAINAGE WICK
K885232 · HOZ
Visitec Co.
Ophthalmic · 50d
Cleared Feb 08, 1989
ACETABULAR CUP PUSHER/IMPACTOR
K885305 · HXO
Cobot Medical Corp.
Orthopedic · 43d
Cleared Feb 08, 1989
DACOMED EXTERNAL MALE CONTINENCE DEVICE
K885323 · FHA
Dacomed Corp.
Gastroenterology & Urology · 42d
Cleared Feb 08, 1989
ZIPPIE & QUICKIE 2HP WHEELCHAIR
K890050 · IOR
Motion Designs, Inc.
Physical Medicine · 33d
Cleared Feb 08, 1989
M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.
K890054 · JDI
Protek, Inc.
Orthopedic · 33d
Cleared Feb 08, 1989
GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER
K890111 · FJI
Gambro, Inc.
Gastroenterology & Urology · 28d
Cleared Feb 08, 1989
CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G
K890315 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 16d
Cleared Feb 07, 1989
CRACK-IT CHAP SCREEN
K874389 · DMN
Sakers, Inc.
Toxicology · 469d
Cleared Feb 07, 1989
STANBIO MAGNESIUM TEST SET, CAT. NO 0130
K883170 · JGJ
Stanbio Laboratory
Chemistry · 195d
Cleared Feb 07, 1989
ORTHO* TOXOPLASMA-G ANTIBODY ELISA TEST
K883937 · LGD
Ortho Diagnostic Systems, Inc.
Microbiology · 141d
Cleared Feb 07, 1989
CEDIA THEOPHYLLINE ASSAY
K884358 · KLS
Microgenics Corp.
Toxicology · 113d
Cleared Feb 07, 1989
BACTIGEN(R) MENINGITIDIS PANEL
K884965 · GWC
Armkel, LLC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) S. PNEUMONIAE
K884966 · GWC
Armkel, LLC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) H. INFLUENZAE TYPE B
K884967 · GRP
Armkel, LLC
Microbiology · 69d
Cleared Feb 07, 1989
BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
K885003 · GTZ
Armkel, LLC
Microbiology · 68d