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
8425–8448 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 25, 1999
MAERSK MEDICAL CONTOUR INFUSION SET
K991759 · FPA
Maersk Medical A/S
General Hospital · 32d
Cleared Jun 24, 1999
HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS...
K984116 · FRF
Abatement Technologies, Inc.
General Hospital · 219d
Cleared Jun 24, 1999
TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC
K990020 · FMF
Te ME NA S.A.R.L.
General Hospital · 171d
Cleared Jun 24, 1999
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM
K991653 · FPA
Rymed Technologies, Inc.
General Hospital · 42d
Cleared Jun 24, 1999
LATEX EXAMINATION GLOVES (POWDER FREE)
K991689 · LYY
Usg Healthguard Sdn Bhd
General Hospital · 37d
Cleared Jun 24, 1999
LATEX EXAMINATION GLOVES (PRE POWDERED)
K991690 · LYY
Usg Healthguard Sdn Bhd
General Hospital · 37d
Cleared Jun 23, 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
K990876 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 99d
Cleared Jun 23, 1999
MINIMED 407C INFUSION PUMP, MODEL 407C
K991013 · FRN
Medtronic Minimed
General Hospital · 89d
Cleared Jun 23, 1999
HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K991304 · LZA
M.R.G. Industries Sdn. Bhd.
General Hospital · 68d
Cleared Jun 23, 1999
HAL SCOPE HOLDER SYSTEM
K991548 · KKX
Noved Medical
General Hospital · 51d
Cleared Jun 23, 1999
ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION...
K991743 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 23, 1999
SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH...
K991744 · LZA
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 23, 1999
ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A...
K991745 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 23, 1999
ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH...
K991746 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 23, 1999
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150...
K991748 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 30d
Cleared Jun 23, 1999
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50...
K991749 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 30d
Cleared Jun 23, 1999
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50...
K991750 · LYY
Brightsway Holdings Sdn Bhd
General Hospital · 30d
Cleared Jun 23, 1999
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150...
K991752 · LYY
Brightsway Holdings Sdn Bhd
General Hospital · 30d
Cleared Jun 21, 1999
POWDER FREE VINYL EXAMINATION GLOVES
K983856 · LYZ
Shijiazhuang Brethern Plastic Co., Ltd.
General Hospital · 231d
Cleared Jun 21, 1999
POWDERED VINYL EXAMINATION GLOVE
K983893 · LYZ
Shijiazhuang Brethern Plastic Co., Ltd.
General Hospital · 231d
Cleared Jun 21, 1999
SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K990186 · LZA
Shanghai Intco. Plastic & Rubber...
General Hospital · 152d
Cleared Jun 21, 1999
MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM...
K991153 · LYY
Medtexx Industries (Thai) Co. , Ltd.
General Hospital · 76d
Cleared Jun 21, 1999
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES
K991155 · LYY
C.V. Anlis Abadi International
General Hospital · 76d
Cleared Jun 21, 1999
HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
K991305 · LYY
M.R.G. Industries Sdn. Bhd.
General Hospital · 66d