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
6793–6816 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 08, 2003
TERUMO SURGUARD 2 SAFETY NEEDLE
K031453 · FMI
Terumo Medical Corp.
General Hospital · 62d
Cleared Jul 07, 2003
VENTLAB BACTERIAL FILTER, MODEL BF100
K030271 · CAH
Ventlab Corp.
General Hospital · 161d
Cleared Jul 07, 2003
DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136,...
K031905 · FLL
Actherm, Inc.
General Hospital · 17d
Cleared Jul 02, 2003
LIFEVALVE CENTRAL VENOUS CATHTER
K031718 · LJS
Horizon Medical Products, Inc.
General Hospital · 29d
Cleared Jul 01, 2003
JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK &...
K023668 · FPA
Jms North America Corp.
General Hospital · 243d
Cleared Jul 01, 2003
SAFE-CONNECT DRUG DISPENSING SPIKE, MODELS SC 4020, SC 4015, SC 4010, SC 4005
K031783 · FPA
Intravascular Incorporated
General Hospital · 21d
Cleared Jun 30, 2003
FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE
K031754 · LYY
Pt. Mandiri Inti Buana
General Hospital · 91d
Cleared Jun 27, 2003
YA MEI FIRST AID KIT
K031130 · KGO
Ya Mei Technology Co., Ltd.
General Hospital · 79d
Cleared Jun 26, 2003
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE...
K031414 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 52d
Cleared Jun 26, 2003
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND...
K031591 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 36d
Cleared Jun 25, 2003
H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM
K014013 · FLF
H & W Technology, LLC
General Hospital · 567d
Cleared Jun 25, 2003
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
K030990 · CAH
Datex-Ohmeda
General Hospital · 89d
Cleared Jun 24, 2003
CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM...
K024270 · CAH
Intersurgical, Inc.
General Hospital · 183d
Cleared Jun 24, 2003
MODIFICATION TO TRANSPORT INCUBATOR 185
K031096 · FPL
International Biomedics, Inc.
General Hospital · 78d
Cleared Jun 24, 2003
MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
K031200 · FMI
Becton, Dickinson & CO
General Hospital · 69d
Cleared Jun 23, 2003
SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
K031065 · MEG
Syringex Medical, Inc.
General Hospital · 81d
Cleared Jun 23, 2003
VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
K031556 · FLL
Vivant Medical, Inc.
General Hospital · 35d
Cleared Jun 20, 2003
DATEX-OHMEDA HMEF 750
K031653 · CAH
Datex-Ohmeda
General Hospital · 23d
Cleared Jun 19, 2003
SOLUTION FACE MASKS
K031353 · FXX
A Plus International, Inc.
General Hospital · 51d
Cleared Jun 19, 2003
ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
K031626 · LJS
AngioDynamics, Inc.
General Hospital · 23d
Cleared Jun 17, 2003
MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK...
K030531 · LZG
Minimed, Inc.
General Hospital · 118d
Cleared Jun 17, 2003
MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR,...
K031384 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 47d
Cleared Jun 13, 2003
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K031021 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 74d
Cleared Jun 13, 2003
CORD STICK MULTIPLE DRAW SYSTEM
K031058 · FMI
Cord Stick Corp.
General Hospital · 71d