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
8497–8520 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 13, 1999
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE
K990698 · LZA
Omnigrace (Thailand) , Ltd.
General Hospital · 71d
Cleared May 13, 1999
FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES
K990729 · MQX
Acc Intl.
General Hospital · 69d
Cleared May 13, 1999
30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS,...
K991363 · FRN
Sorenson Medical, Inc.
General Hospital · 23d
Cleared May 13, 1999
ACCLAIM INFUSION PUMP
K991501 · FRN
Abbott Laboratories
General Hospital · 14d
Cleared May 12, 1999
1000 PRESSURE INFUSION SIGMACON 1000
K990447 · FRN
Valley West, Inc.
General Hospital · 89d
Cleared May 05, 1999
GAS PLASMA STERILIZATION
K972774 · JWH
Zimmer, Inc.
General Hospital · 650d
Cleared May 05, 1999
ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER
K984189 · FOZ
Maxxim Medical
General Hospital · 163d
Cleared May 05, 1999
ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
K984496 · KDQ
Atrium Medical Corp.
General Hospital · 139d
Cleared May 05, 1999
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE
K990701 · LZA
Omnigrace (Thailand) , Ltd.
General Hospital · 63d
Cleared May 05, 1999
BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES
K991085 · LYZ
Long First (Xiamen) Co., Ltd.
General Hospital · 36d
Cleared May 04, 1999
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES
K983982 · KGO
Maxxim Medical
General Hospital · 176d
Cleared May 04, 1999
SKINSENSE NITRILE POWDER-FREE SYNTHETIC MEDICAL EXAMINATION GLOVE
K984249 · LZA
London International Group, Inc.
General Hospital · 155d
Cleared May 04, 1999
DBC, DONG BANG ACUPUNCTURE NEEDLES
K990328 · MQX
Morning Star, Dong Bang Acupuncture...
General Hospital · 91d
Cleared May 04, 1999
TA CHIA POWDERED NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
K990575 · LZA
Ta Chia Rubber Ind. Corp.
General Hospital · 70d
Cleared May 04, 1999
TA CHIA POWDER FREE NON-STERILE NITRILE PATIENT EXAMINATION GLOVES
K990577 · LZA
Ta Chia Rubber Ind. Corp.
General Hospital · 70d
Cleared May 04, 1999
POWDER FREE LATEX EXAMINATION GLOVES
K990686 · LYY
Tower Rubber Industries Sdn. Bhd.
General Hospital · 62d
Cleared May 04, 1999
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE
K990695 · LZA
Omnigrace (Thailand) , Ltd.
General Hospital · 62d
Cleared May 04, 1999
OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN...
K990702 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 62d
Cleared May 04, 1999
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50...
K990812 · LYY
Ampri Rubberware Industries Sdn Bhd
General Hospital · 54d
Cleared May 04, 1999
POWDER FREE LATEX EXAMINATION GLOVES
K990901 · LYY
Apl Products Sdn. Bhd.
General Hospital · 47d
Cleared May 04, 1999
BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES
K990946 · LYZ
Long First (Xiamen) Co., Ltd.
General Hospital · 43d
Cleared May 04, 1999
LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN
K991043 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 36d
Cleared Apr 30, 1999
CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM...
K983610 · CAH
Intersurgical, Inc.
General Hospital · 198d
Cleared Apr 27, 1999
LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING
K990468 · LYY
Top Glove Sdn. Bhd.
General Hospital · 70d