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
8305–8328 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 27, 1999
PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER
K992117 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 96d
Cleared Sep 27, 1999
NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE
K992558 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 59d
Cleared Sep 27, 1999
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE
K992810 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 38d
Cleared Sep 24, 1999
SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
K990253 · KKX
Amba Medical , Ltd.
General Hospital · 240d
Cleared Sep 24, 1999
EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K992175 · LYY
Ultrawin Sdn Bhd
General Hospital · 88d
Cleared Sep 24, 1999
QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES
K992671 · LZA
Latexx Partners Bhd.
General Hospital · 45d
Cleared Sep 24, 1999
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR
K992686 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 45d
Cleared Sep 24, 1999
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
K992860 · LYZ
Shijiazhuang Hongray Plastic Products...
General Hospital · 30d
Cleared Sep 22, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH...
K992364 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 69d
Cleared Sep 22, 1999
CONVERTORS SURGICAL GOWNS
K992951 · FYA
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Sep 15, 1999
BOLUS ACCESSORY SET
K992072 · FPA
I-Flow Corp.
General Hospital · 88d
Cleared Sep 15, 1999
NAC PRN NEEDLELESS ACCESS CONNECTOR
K992268 · FPA
The Kipp Group
General Hospital · 71d
Cleared Sep 14, 1999
DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH...
K992128 · LYY
Dash Medical Gloves Sdn Bhd
General Hospital · 83d
Cleared Sep 14, 1999
COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT...
K992171 · KGO
Allegiance Healthcare Corp.
General Hospital · 78d
Cleared Sep 14, 1999
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992464 · LYZ
Shijiazhuang Dilly Plastics Products...
General Hospital · 53d
Cleared Sep 14, 1999
QUALATEX POWDERED LATEX EXAMINATION GLOVES
K992557 · LYY
Tan Sin Lian Industries Sdn. Bhd.
General Hospital · 46d
Cleared Sep 14, 1999
CONTROL III ELITE
K992661 · LRJ
Maril Products, Inc.
General Hospital · 36d
Cleared Sep 14, 1999
HWA (AND) SILKTEX PRE-POWDERED LATEX EXAMINATION GLOVE
K992730 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 32d
Cleared Sep 13, 1999
ENDO-SPOR PLUS / HYPROCIDE
K972708 · MED
Cottrell, Ltd.
General Hospital · 784d
Cleared Sep 13, 1999
ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING...
K992417 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 55d
Cleared Sep 13, 1999
ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH...
K992418 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 55d
Cleared Sep 13, 1999
ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH...
K992419 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 55d
Cleared Sep 10, 1999
FREEDOM INFUSION SYSTEM
K992015 · MEB
Novacon Corp.
General Hospital · 87d
Cleared Sep 10, 1999
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
K992210 · LZA
Safeskin Corp.
General Hospital · 71d