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
8521–8544 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 23, 1999
CHALLENGE TEST PACK
K983451 · JOJ
North American Science Assoc., Inc.
General Hospital · 205d
Cleared Apr 23, 1999
SIDEKICK INFUSION KIT
K990425 · FRN
I-Flow Corp.
General Hospital · 71d
Cleared Apr 23, 1999
ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE
K990427 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 71d
Cleared Apr 23, 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR
K990485 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 66d
Cleared Apr 23, 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.
K990486 · LZA
Alliance Rubber Products Sdn. Bhd.
General Hospital · 66d
Cleared Apr 23, 1999
KLEENHANDS POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K990526 · LYY
Ssn Gloves (M) Sdn Bhd
General Hospital · 63d
Cleared Apr 23, 1999
KLEENHANDS POWDERED LATEX EXAMINATION GLOVES
K990527 · LYY
Ssn Gloves (M) Sdn Bhd
General Hospital · 63d
Cleared Apr 23, 1999
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT...
K991044 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 24d
Cleared Apr 23, 1999
MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN...
K991294 · KZE
Medi-Ject Corp.
General Hospital · 8d
Cleared Apr 22, 1999
AVIA PAIN MEDICATION DELIVERY SYSTEM
K990312 · MEA
Amtec Medical
General Hospital · 80d
Cleared Apr 21, 1999
DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950
K990371 · FMI
Post Medical, Inc.
General Hospital · 72d
Cleared Apr 20, 1999
PHOTOTHERAPY LAMP
K984589 · LBI
Medela, Inc.
General Hospital · 117d
Cleared Apr 19, 1999
MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
K990189 · FLE
Midmark Corp.
General Hospital · 89d
Cleared Apr 16, 1999
KINGLI ACUPUNCTURE NEEDLE
K990406 · MQX
United Pacific Co., Ltd.
General Hospital · 66d
Cleared Apr 16, 1999
CONVERTORS SURGICAL GOWNS
K991034 · FYA
Allegiance Healthcare Corp.
General Hospital · 18d
Cleared Apr 13, 1999
BARRIER SURGICAL GOWNS
K990395 · FYA
Johnson & Johnson Medical, Div. of...
General Hospital · 63d
Cleared Apr 13, 1999
CODAN CHEMOSPIKE
K990711 · LHI
Codan US Corp.
General Hospital · 40d
Cleared Apr 09, 1999
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
K984059 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 147d
Cleared Apr 09, 1999
ELASTYLON POWDER-FREE SURGICAL GLOVE
K984337 · KGO
Eci Medical Technologies, Inc.
General Hospital · 127d
Cleared Apr 09, 1999
TOP WHOLESOME FACE MASK
K984389 · FXX
Top Wholesome Enterprise Co., Ltd.
General Hospital · 122d
Cleared Apr 09, 1999
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE)
K990539 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 09, 1999
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)
K990540 · LYY
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 09, 1999
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE)
K990541 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 46d
Cleared Apr 09, 1999
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K990542 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 46d