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
5113–5136 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 30, 2009
MODIFICATION TO AUTOFUSER
K090300 · MEB
Ace Medical Us, LLC
General Hospital · 83d
Cleared Apr 29, 2009
MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292
K090569 · FRC
3M Company
General Hospital · 58d
Cleared Apr 28, 2009
MPS ACACIA POWER INJECTABLE INFUSION SET
K090809 · FPA
Mps Acacia
General Hospital · 34d
Cleared Apr 28, 2009
SWABCAP
K083508 · QBP
Excelsior Medical Corp.
General Hospital · 153d
Cleared Apr 27, 2009
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
K090905 · LHI
B.Braun Medical, Inc.
General Hospital · 26d
Cleared Apr 27, 2009
DS N95 SURGICAL MASKS AND FLAT SURGICAL
K090131 · MSH
Shanghai Dasheng Health Products
General Hospital · 96d
Cleared Apr 27, 2009
SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE
K083931 · LYZ
Quantum Co., Ltd.
General Hospital · 143d
Cleared Apr 24, 2009
BILI BLUE F20T12/BBY AND F40T12/BBY
K090192 · LBI
Interlectric Corp.
General Hospital · 87d
Cleared Apr 24, 2009
MOBILECARE MONITOR, MODEL 2100
K090138 · KMI
Aframe Digital, Inc.
General Hospital · 93d
Cleared Apr 24, 2009
NOVAGUARD, MODEL 3611001
K082908 · FMI
West Pharmaceutical Services, Inc.
General Hospital · 206d
Cleared Apr 24, 2009
SKLAR SURGICAL GOWN
K082479 · FYA
Sklar Corp.
General Hospital · 239d
Cleared Apr 23, 2009
BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE
K090464 · LZA
Pt Mahakarya Inti Buana
General Hospital · 59d
Cleared Apr 21, 2009
INTRAVENOUS POWER INJECTOR EXTENSION SET
K090134 · FPA
C.R. Bard, Inc.
General Hospital · 90d
Cleared Apr 16, 2009
MODIFICATION TO: GIRAFFE AND PANDA WARMER
K090697 · FMT
Ohmeda Medical
General Hospital · 30d
Cleared Apr 16, 2009
ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES
K090031 · FLL
Actherm, Inc.
General Hospital · 101d
Cleared Apr 15, 2009
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
K082997 · FOZ
Terumo Medical Corp.
General Hospital · 189d
Cleared Apr 10, 2009
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
K090189 · FPA
Icu Medical, Inc.
General Hospital · 74d
Cleared Apr 10, 2009
BLOOD TRANSFUSION SET
K083349 · BRZ
Shan Dong Wei Gao Group Medical...
General Hospital · 148d
Cleared Apr 07, 2009
MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM
K090087 · FRN
Iradimed Corporation
General Hospital · 84d
Cleared Apr 06, 2009
SPINNING SPIROS, MODEL CH-2000
K082806 · FPA
Icu Medical, Inc.
General Hospital · 194d
Cleared Apr 03, 2009
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN...
K090327 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 53d
Cleared Apr 02, 2009
ZETAJET
K090003 · KZE
Bioject, Inc.
General Hospital · 90d
Cleared Apr 02, 2009
COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET
K083482 · FPA
Cook Vascular, Inc.
General Hospital · 129d
Cleared Mar 27, 2009
POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX...
K090512 · LJT
C.R. Bard, Inc.
General Hospital · 29d