FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,754 results
8953–8976 of 17,754
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 10, 1998
CASTLE SERIES 200 STEAM STERILIZER (POWERCLAVE)
K973225 · FLE
Getinge/Castle, Inc.
General Hospital · 167d
Cleared Feb 10, 1998
STERILE SALINE FOR CATHETER CARE
K974397 · JOL
Baxter Healthcare Corp
General Hospital · 81d
Cleared Feb 10, 1998
L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT...
K974543 · FOZ
Luther Medical Products, Inc.
General Hospital · 69d
Cleared Feb 09, 1998
ELASTYREN POWDER-FREE SURGICAL GLOVE
K971471 · KGO
Eci Medical Technologies, Inc.
General Hospital · 292d
Cleared Feb 09, 1998
ENCORE MARK IV POWDER FREE SURGICAL GLOVES
K974783 · KGO
Ansell Perry
General Hospital · 49d
Cleared Feb 09, 1998
LATEX (POWDER FREE) LOW PROTEIN
K974853 · LYY
P.T. Healthcare Glovindo
General Hospital · 42d
Cleared Feb 09, 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
K980037 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 35d
Cleared Feb 09, 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K980038 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 35d
Cleared Feb 09, 1998
POWDERED GREEN LATEX EXAMINATION GLOVES
K980039 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 35d
Cleared Feb 09, 1998
POWDER-FREE NITRILE EXAMINATION GLOVES
K980150 · LZA
Masju Sdn. Bhd.
General Hospital · 24d
Cleared Feb 05, 1998
STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION
K973734 · JOL
Welcon, Inc.
General Hospital · 128d
Cleared Feb 05, 1998
SINGER ACUPUNCTURE NEEDLES
K974616 · MQX
Lorac, Inc.
General Hospital · 56d
Cleared Feb 04, 1998
FLEXIBLE TIP DIGITAL THERMOMETER
K974195 · FLL
K-Jump Health Co., Ltd.
General Hospital · 89d
Cleared Feb 02, 1998
MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
K974163 · FPA
Medtronic Minimed
General Hospital · 89d
Cleared Jan 30, 1998
VINYL EXAMINATION GLOVES POWDER FREE
K974777 · LYZ
Sun Flower Gloves Co., Ltd.
General Hospital · 39d
Cleared Jan 30, 1998
POWDERED GREEN NITRILE EXAMINATION GLOVES
K974886 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 31d
Cleared Jan 29, 1998
BROWNE MVI STEAM INDICATOR
K971369 · JOJ
Albert Browne , Ltd.
General Hospital · 290d
Cleared Jan 29, 1998
EASYSAFE RETRACTING NEEDLE SYRINGE
K973792 · MEG
Saf-T-Med, Inc.
General Hospital · 115d
Cleared Jan 29, 1998
SAFEPASS STERILIZATION POUCH
K973981 · KCT
Adroit Medical Systems, Inc.
General Hospital · 101d
Cleared Jan 29, 1998
ZEROWET SPLASHIELD
K974288 · KYZ
Zerowet, Inc.
General Hospital · 76d
Cleared Jan 29, 1998
SURGEON'S GLOVES
K974356 · KGO
American Health Products, Inc.
General Hospital · 71d
Cleared Jan 29, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES
K974887 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 30d
Cleared Jan 29, 1998
POWDERED NITRILE EXAMINATION GLOVES
K980149 · LZA
Masju Sdn. Bhd.
General Hospital · 13d
Cleared Jan 23, 1998
MCKINLEY OUTBOUND-2 SYSTEM
K971844 · FPA
Mckinley, Inc.
General Hospital · 249d