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
3841–3864 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 12, 2013
JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
K124037 · FMF
Jung Rim Medical Industrial Co., Ltd.
General Hospital · 258d
Cleared Sep 12, 2013
SURGICAL GOWN (EO STERILIZED)
K112796 · FYA
Cobes Industries Co., Ltd.
General Hospital · 717d
Cleared Sep 09, 2013
POWER FREE VINYL EXAMINATION GLOVES
K122102 · LYZ
Wang Tong Xinghua Co., Ltd.
General Hospital · 420d
Cleared Sep 06, 2013
K-PACK II NEEDLE - 27G X 3/4 THIN WALL
K132233 · FMI
Terumo Europe N.V.
General Hospital · 50d
Cleared Sep 06, 2013
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
K121844 · LYY
Worldmed Manufacturing Sdn. Bhd.
General Hospital · 438d
Cleared Aug 30, 2013
RESTORE MODULAR STERILIZATION TRAY SYSTEM
K131455 · KCT
Restore Medical Solutions, Inc.
General Hospital · 102d
Cleared Aug 29, 2013
MZ1000
K132413 · FPA
Care Fusion
General Hospital · 27d
Cleared Aug 29, 2013
OMNIPOD INSULIN MANAGEMENT SYSTEM
K131294 · LZG
Insulet Corporation
General Hospital · 115d
Cleared Aug 28, 2013
MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)
K131641 · FMF
Nipro Medical Corporation
General Hospital · 85d
Cleared Aug 28, 2013
SONICISION STERILIZATION TRAY
K131170 · KCT
Covidien, Formerly Valleylab, A...
General Hospital · 126d
Cleared Aug 28, 2013
UGFT3
K131155 · FLL
Medisim, Ltd.
General Hospital · 126d
Cleared Aug 28, 2013
POWDERED LATEX SURGEON'S GLOVE
K121925 · KGO
Suzhou Colour-Way Enterprise...
General Hospital · 422d
Cleared Aug 27, 2013
IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET
K123987 · JKA
Innovative Medical Technologies, Inc.
General Hospital · 244d
Cleared Aug 22, 2013
LATEX SURGEON'S GLOVES (POWDERED AND POWDER FREE)
K130301 · KGO
Elimedical Devices (Fujian), Inc.
General Hospital · 196d
Cleared Aug 22, 2013
POWDERED VINYL EXAMINATION GLOVES
K122100 · LYZ
Wang Tong Xinghua Co., Ltd.
General Hospital · 402d
Cleared Aug 20, 2013
STERICAN CANNULA
K131842 · FMI
B.Braun Medical, Inc.
General Hospital · 60d
Cleared Aug 20, 2013
KIMGUARD ONE STEP STERILIZATION WRAP
K113806 · FRG
Kimberly-Clark Health Care
General Hospital · 606d
Cleared Aug 16, 2013
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET
K132334 · LJS
Cook, Inc.
General Hospital · 21d
Cleared Aug 16, 2013
6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET
K131687 · LJS
Medical Components, Inc.
General Hospital · 67d
Cleared Aug 16, 2013
VERIFY PROCESS INDICATOR FOR RELIANCE EPS
K130160 · JOJ
STERIS Corporation
General Hospital · 205d
Cleared Aug 15, 2013
DYNASENSE SYSTEM
K130752 · KMI
Centauri Medical, Inc.
General Hospital · 149d
Cleared Aug 15, 2013
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
K123766 · FMF
Novo Nordisk, Inc.
General Hospital · 251d
Cleared Aug 14, 2013
MULTIBOLUS II DISPOSABLE PAIN MANAGEMENT SYSTEM
K131247 · MEB
Mfs - Medical Flow Systems, Ltd.
General Hospital · 105d
Cleared Aug 13, 2013
EVICEL APPLICATION DEVICE
K130900 · FMF
Ethicon Inc (On Behalf of Omrix...
General Hospital · 134d