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
8401–8424 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 26, 1999
SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES...
K991951 · LYZ
Safeskin Corp.
General Hospital · 46d
Cleared Jul 26, 1999
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)
K992020 · KGO
Brightsway Holdings Sdn Bhd
General Hospital · 40d
Cleared Jul 23, 1999
BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)
K992021 · KGO
Brightsway Holdings Sdn Bhd
General Hospital · 37d
Cleared Jul 23, 1999
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
K992205 · LYZ
Shanghai China Star Corp
General Hospital · 23d
Cleared Jul 15, 1999
TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE
K992122 · LYZ
Maxxim Medical
General Hospital · 22d
Cleared Jul 14, 1999
PRO-PORTION CLEANER/DISINFECTANT
K991509 · LRJ
Sultan Chemists, Inc.
General Hospital · 75d
Cleared Jul 14, 1999
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING...
K991616 · LYY
Hartalega Sdn Bhd
General Hospital · 65d
Cleared Jul 13, 1999
ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES
K991992 · KGO
Allegiance Healthcare Corp.
General Hospital · 29d
Cleared Jul 12, 1999
NITRILON CORRECT-TOUCH
K984512 · KGO
Ct Intl.
General Hospital · 206d
Cleared Jul 12, 1999
EARLOOP FACE MASK
K990719 · FXX
Shuenn Bao Shing Corp.
General Hospital · 129d
Cleared Jul 12, 1999
PASS/FAIL CHALLENGE PACK
K991276 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 89d
Cleared Jul 12, 1999
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)
K991940 · KGO
Brightway Holdings Sdn. Bhd.
General Hospital · 33d
Cleared Jul 12, 1999
LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50...
K992031 · LYY
Shanghai Changzheng Latex Factory
General Hospital · 26d
Cleared Jul 09, 1999
TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE
K990761 · FRG
Tuttnauer U.S.A Co, Ltd.
General Hospital · 123d
Cleared Jul 09, 1999
GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K991554 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 67d
Cleared Jul 09, 1999
POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES
K991624 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 59d
Cleared Jul 08, 1999
MTI 1 ML SYRINGE
K991225 · FMF
Micro Therapeutics, Inc.
General Hospital · 87d
Cleared Jul 07, 1999
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING...
K991849 · LYY
Seal Polymer Industries Bhd.
General Hospital · 36d
Cleared Jul 01, 1999
ANESFLOW-DUAL DRIP IV INFUSION SET
K990496 · FPA
Innovative Design Assoc.
General Hospital · 134d
Cleared Jul 01, 1999
WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS
K991275 · FRN
Mckinley, Inc.
General Hospital · 78d
Cleared Jul 01, 1999
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
K991457 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 66d
Cleared Jul 01, 1999
NITRILE EXAMINATION GLOVE, POWDERED, BLUE
K991821 · LZA
Ning BO Yujiang Rubber & Plastic Co.
General Hospital · 35d
Cleared Jul 01, 1999
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)
K991939 · KGO
Brightway Holdings Sdn. Bhd.
General Hospital · 22d
Cleared Jun 30, 1999
MCKINLEY SP DISPOSABLE INFUSION PUMP
K990461 · MEB
Mckinley, Inc.
General Hospital · 138d