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
8065–8088 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 10, 2000
BETEL POWDER FREE LATEX EXAM GLOVES, CHLORINATED, WITH PROTEIN LABELING CLAIM...
K000652 · LYY
Betel Care Sdn. Bhd.
General Hospital · 42d
Cleared Apr 07, 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
K000828 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 24d
Cleared Apr 05, 2000
INSYTE CATHETER, INSYTE AUTOGUARD CATHETER
K000235 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 69d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
K000323 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
K000329 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE
K000330 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING...
K000725 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 30d
Cleared Apr 05, 2000
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K000872 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 16d
Cleared Mar 31, 2000
HYDROCISION DEBDRIDEMENT SYSTEM
K991383 · FQH
Hydrocision, Inc.
General Hospital · 345d
Cleared Mar 30, 2000
VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5
K000369 · FMI
Medpro Technologies, Inc.
General Hospital · 55d
Cleared Mar 29, 2000
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN...
K000671 · LYY
Sgmp Co., Ltd.
General Hospital · 30d
Cleared Mar 29, 2000
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992554 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 243d
Cleared Mar 29, 2000
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
K993201 · KGO
Pamitex Industries Sdn Bhd
General Hospital · 187d
Cleared Mar 24, 2000
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY...
K000821 · FRN
Abbott Laboratories
General Hospital · 10d
Cleared Mar 24, 2000
ULTICARE DISPOSABLE SYRINGE
K994230 · FMF
Ultimed, Inc.
General Hospital · 99d
Cleared Mar 20, 2000
VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR...
K000488 · LYY
Sgmp Co., Ltd.
General Hospital · 35d
Cleared Mar 17, 2000
STERIS AMSCO MILLENNIUM STEAM STERILIZER
K000077 · FLE
STERIS Corporation
General Hospital · 66d
Cleared Mar 17, 2000
PORTSETT
K000085 · FMI
Portsett, Inc.
General Hospital · 65d
Cleared Mar 17, 2000
MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR
K000087 · FOZ
The Kendal Co.
General Hospital · 65d
Cleared Mar 17, 2000
CONVERTORS EQUIPMENT DRAPES
K000417 · KKX
Allegiance Healthcare Corp.
General Hospital · 38d
Cleared Mar 17, 2000
SUPERGLOVES STERILE POWDERED LATEX EXAMINATION GLOVES
K000644 · LYY
Supermax Glove Manufacturing Sdn Bhd
General Hospital · 21d
Cleared Mar 17, 2000
SOLOGUARD LOCKING PLUS SYRINGE
K993609 · MEG
Safeguard Medical Products, Inc.
General Hospital · 144d
Cleared Mar 14, 2000
STEAM/EO RECORD CARD, MODEL CI 121
K000502 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 28d
Cleared Mar 13, 2000
CELSITE IMPLANTABLE PORT WITH VALVED CATHETER
K993024 · LJT
B. Braun of America, Inc.
General Hospital · 186d