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
7393–7416 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 07, 2001
COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD...
K013244 · FQM
Med Gen, Inc.
General Hospital · 70d
Cleared Dec 07, 2001
BI-3M NEEDLE-FREE INJECTOR SYSTEM
K013256 · KZE
Felton International, Inc.
General Hospital · 67d
Cleared Dec 07, 2001
LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL...
K013333 · LYY
Innovative Gloves Co;, Ltd.
General Hospital · 59d
Cleared Dec 07, 2001
ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K013537 · LYY
Koon Seng Sdn Bhd
General Hospital · 45d
Cleared Dec 07, 2001
STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G
K013727 · KGO
Smart Glove Corp. Sdn Bhd
General Hospital · 28d
Cleared Dec 07, 2001
METAPAK MULTI-PURPOSE INSTRUMENT TRAY
K993535 · FRG
Riley Medical, Inc.
General Hospital · 780d
Cleared Dec 03, 2001
TRIMAX
K012268 · FYA
Standard Textile Co., Inc.
General Hospital · 137d
Cleared Dec 03, 2001
NIPRO SAFELET CATH
K013287 · FOZ
Nipro Medical Corp.
General Hospital · 62d
Cleared Dec 03, 2001
NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND...
K013288 · LYY
Sgmp Co., Ltd.
General Hospital · 62d
Cleared Dec 03, 2001
SIMPLICITY CLASSIC WING QD INFUSION SET
K013502 · FPA
Sterling Medivations, Inc.
General Hospital · 42d
Cleared Dec 03, 2001
PAIN CARE 3200
K013928 · MEB
Breg, Inc.
General Hospital · 5d
Cleared Nov 29, 2001
NEPTUNE WASTE MANAGEMENT STSTEM
K012991 · FYD
Stryker Instruments
General Hospital · 84d
Cleared Nov 29, 2001
MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE
K013261 · LZA
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 59d
Cleared Nov 29, 2001
HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN...
K013324 · KGO
Tillotson Healthcare Corp.
General Hospital · 55d
Cleared Nov 29, 2001
POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS...
K013443 · LYY
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 43d
Cleared Nov 20, 2001
COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES
K013239 · FMQ
Med Gen, Inc.
General Hospital · 53d
Cleared Nov 20, 2001
DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
K013782 · FMI
Disetronic Medical Systems
General Hospital · 6d
Cleared Nov 16, 2001
SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9
K012819 · KGO
Semperit Technische Produkte Gesellshaft
General Hospital · 85d
Cleared Nov 16, 2001
SMART GLOVE STERILE NITRILE EXAM GLOVE
K012853 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 84d
Cleared Nov 16, 2001
STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G
K012856 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 84d
Cleared Nov 16, 2001
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS)
K012880 · KGO
Ssn Gloves (M) Sdn Bhd
General Hospital · 80d
Cleared Nov 16, 2001
STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200...
K012896 · KGO
Ssn Gloves (M) Sdn Bhd
General Hospital · 80d
Cleared Nov 13, 2001
SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE
K012815 · LYY
Kimberly-Clark Corp.
General Hospital · 83d
Cleared Nov 13, 2001
SINGLE DOSE DISPENSING PIN, MODEL 2201
K013087 · LHI
Alaris Medical Systems, Inc.
General Hospital · 57d