FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
4705–4728 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 03, 2010
POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH...
K101799 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 67d
Cleared Sep 03, 2010
EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL,...
K101593 · FYA
Exact Medical Manufacturing, Inc.
General Hospital · 87d
Cleared Sep 02, 2010
EASY TOUCH
K102178 · FMF
Mhc Medical Products
General Hospital · 30d
Cleared Sep 02, 2010
SHARPS CONTAINER
K101567 · MMK
Cixi Leinuo Plastic Co., Ltd.
General Hospital · 90d
Cleared Sep 02, 2010
NMI IC
K101326 · LJS
Navilyst Medical, Inc.
General Hospital · 114d
Cleared Aug 31, 2010
FASTX STERNAL INTRAOSSEOUS DEVICE
K100124 · FMI
Pyng Medical Corp.
General Hospital · 224d
Cleared Aug 30, 2010
1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1
K100998 · MEG
Unilife Medical Solutions Limited
General Hospital · 140d
Cleared Aug 27, 2010
SUR-G GLOV AND MAXITEX
K102119 · KGO
Terang Nusa Sdn Bhd
General Hospital · 30d
Cleared Aug 27, 2010
ACCU-CHEK ULTRFLEX INFUSION SET
K101196 · FPA
Roche Diagnostics Corp.
General Hospital · 120d
Cleared Aug 27, 2010
ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER...
K100635 · LJS
Arrow Intl., Inc.
General Hospital · 175d
Cleared Aug 27, 2010
BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6
K100622 · FLE
Belimed Sauter AG
General Hospital · 176d
Cleared Aug 26, 2010
NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION...
K101645 · LYY
Latexx Manufacturing Sdn.Bhd.
General Hospital · 76d
Cleared Aug 24, 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K101358 · LYZ
Hebei Handform Plastic Products Co.,...
General Hospital · 102d
Cleared Aug 23, 2010
LUMENVU CATHETER GUIDANCE SYSTEM
K093510 · OMF
Sonosite,Inc.
General Hospital · 284d
Cleared Aug 20, 2010
INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)
K101359 · FMF
Inviro Medical Devices, Inc.
General Hospital · 98d
Cleared Aug 20, 2010
ZIRCONIA SYRINGE NEEDLE
K093043 · FMI
Kuo Tai Hospital Managements &...
General Hospital · 324d
Cleared Aug 19, 2010
SYNERGY CT PICC
K101329 · LJS
Health Line International Corporation
General Hospital · 99d
Cleared Aug 17, 2010
POWDER - FREE PATIENT EXAMINATION GLOVES
K101565 · LYZ
Zibio Yingjie Medical Products Co., Ltd.
General Hospital · 74d
Cleared Aug 17, 2010
HUMAPEN LUXURA HD
K100988 · FMF
Eli Lilly and Company
General Hospital · 130d
Cleared Aug 17, 2010
NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED,...
K100975 · LZA
Jiangsu Sunshine Plastic Products,...
General Hospital · 130d
Cleared Aug 17, 2010
ABREU, MODEL 700
K100843 · FLL
Brain Tunnelgenix Technologies Corp
General Hospital · 145d
Cleared Aug 16, 2010
IMC SURGICAL FACE MASK
K100846 · FXX
International Medsurg Connection
General Hospital · 144d
Cleared Aug 12, 2010
POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE
K100978 · LYZ
Jiangsu Sunshine Plastic Products,...
General Hospital · 126d
Cleared Aug 12, 2010
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE
K100977 · LYZ
Jiangsu Sunshine Plastic Products,...
General Hospital · 126d