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
7153–7176 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 02, 2002
DISETRONIC D-TRON INSULIN INFUSION PUMP
K021725 · LZG
Disetronic Medical Systems AG
General Hospital · 70d
Cleared Aug 02, 2002
MEDTEXX POWDERFREE NITRILE RUBBER EXAMINATION GLOVES, GREEN COLOUR
K022101 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 35d
Cleared Aug 02, 2002
MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
K022246 · FMF
Depuyacromed
General Hospital · 21d
Cleared Aug 02, 2002
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, &...
K022317 · LZG
Sooil Development Co., Ltd.
General Hospital · 16d
Cleared Aug 01, 2002
PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
K013093 · CAH
Pall Medical
General Hospital · 318d
Cleared Aug 01, 2002
LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
K020040 · LYY
Pt. Maja Agung Latexindo
General Hospital · 206d
Cleared Aug 01, 2002
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL...
K021452 · LZA
Maxxim Medical
General Hospital · 87d
Cleared Aug 01, 2002
DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR, POWDER FREE WITH VITAMIN E
K021853 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 56d
Cleared Aug 01, 2002
TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES
K021950 · LYY
Top Glove Medical (Thailand) Co., Ltd.
General Hospital · 49d
Cleared Aug 01, 2002
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)
K022024 · LZA
Best Manufacturing Company
General Hospital · 42d
Cleared Aug 01, 2002
STRYKER T4 URETHANE HOOD
K022162 · FYA
Stryker Instruments
General Hospital · 29d
Cleared Aug 01, 2002
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · MEA
Abbott Laboratories
General Hospital · 27d
Cleared Jul 30, 2002
HYCARE LATEX EXAMINATION GLOVE, POWDER FREE
K020042 · LYY
Hycare Intl. Co., Ltd.
General Hospital · 204d
Cleared Jul 30, 2002
WA RUBBERMATE LATEX POWDER-FREE EXAM GLOVES
K021041 · LYY
W.A. Rubbermate Co., Ltd.
General Hospital · 120d
Cleared Jul 25, 2002
TUTTNAUER EHS SERIES TABLE-TOP AUTOCLAVE, MODEL 2540
K021504 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 77d
Cleared Jul 24, 2002
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE...
K021784 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 55d
Cleared Jul 23, 2002
PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007
K012974 · FLL
Prizm Medical, Inc.
General Hospital · 321d
Cleared Jul 23, 2002
MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95
K020474 · MSH
Makrite Industries, Inc.
General Hospital · 161d
Cleared Jul 23, 2002
INJEX 30 NEEDLE FREE INJECTION SYSTEM
K022148 · KZE
Equidyne Systems, Inc.
General Hospital · 21d
Cleared Jul 19, 2002
BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET
K021475 · FMI
Bd
General Hospital · 72d
Cleared Jul 18, 2002
QIZHOU ACUPUNCTURE NEEDLE
K013926 · MQX
Wujiang City Shenli Medical and...
General Hospital · 232d
Cleared Jul 18, 2002
STEAMPLUS STERILIZATION TEST
K020409 · JOJ
Spsmedical Supply Corp.
General Hospital · 161d
Cleared Jul 18, 2002
V-2100G ADVANCED INFANT INCUBATOR
K021809 · FMZ
Atom Medical Corp
General Hospital · 45d
Cleared Jul 17, 2002
DIGITAL CLINICAL THERMOMETER, MODEL KD-193
K021851 · FLL
K-Jump Health Co., Ltd.
General Hospital · 42d