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
124441–124464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 1990
ABBOTT VISION LYTE (TM) SODIUM
K903188 · JGS
Abbott Laboratories
Chemistry · 53d
Cleared Sep 10, 1990
CUI ARTICULATED SILICONE CHIN
K903327 · FWP
Cui Corp.
General & Plastic Surgery · 47d
Cleared Sep 10, 1990
CUI PREMAXILLARY IMPLANT
K903328 · FZE
Cui Corp.
General & Plastic Surgery · 47d
Cleared Sep 10, 1990
CUI ANATOMICAL SILICONE MALAR
K903329 · LZK
Cui Corp.
General & Plastic Surgery · 47d
Cleared Sep 10, 1990
TDX FREE T4 CALCULATION
K903383 · CEC
Abbott Laboratories
Chemistry · 45d
Cleared Sep 10, 1990
IMX FREE T4 CALCULATION
K903384 · CEC
Abbott Laboratories
Chemistry · 45d
Cleared Sep 10, 1990
MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH
K903510 · JEQ
Helm Toy Corp.
Dental · 38d
Cleared Sep 10, 1990
DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000)
K903616 · JKC
Diagnostic Systems Laboratories, Inc.
Chemistry · 33d
Cleared Sep 10, 1990
STERNOTOMY CABLE, SONGER CABLE SYSTEM
K903676 · JDQ
Danek Medical, Inc.
Orthopedic · 28d
Cleared Sep 10, 1990
COMPANION 318 NASAL CPAP SYSTEM
K903764 · BYE
Puritan Bennett Corp.
Anesthesiology · 21d
Cleared Sep 10, 1990
FRAME, SPECTACLE
K903949 · HQZ
Eureka Optics, Inc.
Ophthalmic · 13d
Cleared Sep 07, 1990
SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE
K895810 · FMF
Shargh Pharmaceutical Co., Inc.
General Hospital · 343d
Cleared Sep 07, 1990
SHARGHP HYPODERMIC NEEDLE
K895811 · FMI
Shargh Pharmaceutical Co., Inc.
General Hospital · 343d
Cleared Sep 07, 1990
SHARGHP INTRAVENOUS CATHETER
K895812 · FOZ
Shargh Pharmaceutical Co., Inc.
General Hospital · 343d
Cleared Sep 07, 1990
SHARGHP INSULIN SYRINGES
K895980 · FMF
Shargh Pharmaceutical Co., Inc.
General Hospital · 343d
Cleared Sep 07, 1990
SURGICAL COTTON GLOVES
K900425 · LYU
Allo Pro Corp.
General Hospital · 220d
Cleared Sep 07, 1990
OHMEDA UNIVERSAL PAC
K901117 · BSZ
Ohmeda Medical
Anesthesiology · 183d
Cleared Sep 07, 1990
F-24 FEMORAL HIP PROSTHESIS
K901687 · LWJ
Med-Tek Corp.
Orthopedic · 148d
Cleared Sep 07, 1990
DEGUFLEX (R) CS LIGHT
K901866 · ELW
Degussa AG
Dental · 136d
Cleared Sep 07, 1990
C3C AND C4 RID KITS
K902382 · CZW
The Binding Site, Ltd.
Chemistry · 100d
Cleared Sep 07, 1990
ACID PHOSPHOTASE REAGENT TEST AND KIT
K902543 · CKB
Crestat Diagnostics, Inc.
Chemistry · 93d
Cleared Sep 07, 1990
ROCHE COBAS READY CREATININE REAGENT
K902561 · CGX
Roche Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Sep 07, 1990
ENDOSCOPIC HEMOSTATIC LIGATING LOOP
K902731 · GAL
United States Surgical, A Division of...
General & Plastic Surgery · 78d
Cleared Sep 07, 1990
ABBOTT IMX FREE T4
K902834 · CEC
Abbott Laboratories
Chemistry · 71d