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
9001–9024 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Jan 23, 1998
MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
K974682 · FRF
Biological Controls, Inc.
General Hospital · 39d
Cleared Jan 22, 1998
ZAK-2000
K972022 · FNM
Cardio Systems, Inc.
General Hospital · 234d
Cleared Jan 22, 1998
BECTON DICKINSON TWINPAK
K974006 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 93d
Cleared Jan 22, 1998
ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA
K974122 · MQX
Scientific Health Care
General Hospital · 83d
Cleared Jan 22, 1998
MIGHTY AIR
K974319 · FNM
Wheelchairs of Kansas
General Hospital · 66d
Cleared Jan 22, 1998
PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, PORT-A-CATH II DUAL LUMEN LOW...
K974471 · LJT
Sims Deltec, Inc.
General Hospital · 57d
Cleared Jan 16, 1998
POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE
K973830 · LYY
Safe Glove , Ltd.
General Hospital · 101d
Cleared Jan 16, 1998
PDI STERILE LUBRICATING JELLY
K974768 · KMJ
Nice-Pak Products, Inc.
General Hospital · 25d
Cleared Jan 13, 1998
PRIMED SHOE COVERS, PRIMED HEAD COVERS
K971076 · FXP
Primeline Medical Products, Inc.
General Hospital · 295d
Cleared Jan 13, 1998
HUBERLOC
K973497 · LJT
Medcare Medical Group, Inc.
General Hospital · 120d
Cleared Jan 13, 1998
CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS
K974083 · FMG
Ohmeda Medical
General Hospital · 76d