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
5569–5592 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 11, 2007
CLINICAL THERMOMETER/MODEL ZSDT-XXXX DIGITAL THERMOMETER AND ZSET-XXX...
K070578 · FLL
Zen Strong Medical Technology Co., Ltd.
General Hospital · 132d
Cleared Jul 11, 2007
GIRAFFE AND PANDA WARMER
K070377 · FMT
Ohmeda Medical
General Hospital · 153d
Cleared Jul 05, 2007
LIFE LATCH SHARPS & BIOHAZARD CONTAINER
K071088 · FMI
M&M Industries, Inc.
General Hospital · 78d
Cleared Jul 05, 2007
POWDER-FREE VINYL EXAMINATION GLOVES
K071022 · LYZ
Glormed Colombia S.A.
General Hospital · 85d
Cleared Jun 29, 2007
ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT
K070613 · LJS
AngioDynamics, Inc.
General Hospital · 116d
Cleared Jun 29, 2007
TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE
K063681 · FLE
Mediline Italia S.R.L.
General Hospital · 200d
Cleared Jun 29, 2007
A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER
K063526 · CAH
A-M Systems, Inc.
General Hospital · 219d
Cleared Jun 27, 2007
POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH...
K070619 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 114d
Cleared Jun 22, 2007
POWDERED LATEX EXAMINATION GLOVES
K071323 · LYY
Quality Gallant Sdn. Bhd.
General Hospital · 43d
Cleared Jun 22, 2007
TRIFLEX SELECT
K070647 · KGO
Cardinal Health, Inc.
General Hospital · 106d
Cleared Jun 21, 2007
DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200
K070491 · FLL
K-Jump Health Co., Ltd.
General Hospital · 121d
Cleared Jun 20, 2007
FEEL-JECT INSULIN SYRINGE
K070917 · FMF
Feel Tech
General Hospital · 79d
Cleared Jun 15, 2007
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
K070639 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 100d
Cleared Jun 14, 2007
MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
K063876 · FEB
Medivators Reprocessing Systems
General Hospital · 167d
Not Cleared Jun 13, 2007
INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM
DEN060002 · NZH
Inrange Systems, Inc.
General Hospital · 265d
Cleared Jun 08, 2007
HYPERTHERMIA PUMP
K070654 · LGZ
Belmont Instrument Corp.
General Hospital · 91d
Cleared Jun 08, 2007
STERILIZATION POUCH WITH INDICATORS
K062704 · FRG
Winner Industries (Shenzhen) Co., Ltd.
General Hospital · 270d
Cleared Jun 07, 2007
POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE
K070760 · LYY
Derma Care Plus Products, LLC
General Hospital · 79d
Cleared Jun 05, 2007
DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300
K070878 · FLL
Rg Medical Diagnostics
General Hospital · 68d
Cleared Jun 05, 2007
GENIE, MODEL CH-200
K070633 · FMF
Icu Medical, Inc.
General Hospital · 90d
Cleared May 30, 2007
POWDER FREE NITRILE EXAMINATION GLOVES (BLUE, WIHTE)
K070862 · LZA
Purtech Cleanroom Products Co., Ltd.
General Hospital · 63d
Cleared May 30, 2007
MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP
K070814 · FMF
Confluent Surgical,Inc
General Hospital · 65d
Cleared May 30, 2007
DUKAL N95PARTICULATE RESPIRATOR/SURGICAL FACE MASK
K070692 · MSH
Dukal Corporation
General Hospital · 78d
Cleared May 29, 2007
EVICEL APPLICATION DEVICE
K070575 · FMF
Omrix Biopharmaceuticals , Ltd.
General Hospital · 90d