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
9361–9384 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 11, 1997
PATIENT RESTRAINTS
K970274 · FMQ
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 11, 1997
PATIENT RESTRAINTS
K970275 · FMQ
Fla Orthopedics, Inc.
General Hospital · 78d
Cleared Apr 10, 1997
STERILE DISPOSABLE EQUIPMENT MAGNET COVER
K970185 · KKX
Contour Fabricators, Inc.
General Hospital · 83d
Cleared Apr 10, 1997
TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
K970370 · FMI
Tsk Laboratory, Japan
General Hospital · 69d
Cleared Apr 08, 1997
MINIMED INSULIN PUMP, MODEL 505
K963948 · LZG
Medtronic Minimed
General Hospital · 188d
Cleared Apr 08, 1997
E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET
K970259 · FPA
Becton Dickinson Vascular Access, Inc.
General Hospital · 75d
Cleared Apr 07, 1997
LUMBAR PUNCTURE KIT
K970287 · FMJ
B.Braun Medical, Inc.
General Hospital · 73d
Cleared Apr 03, 1997
STANILET FREESTANDING/CC INFANT/2000C INFANT WARMER (1250C/1500C/2000D)
K970074 · FMT
Hill-Rom, Inc.
General Hospital · 85d
Cleared Apr 02, 1997
STERITEC DRY HEAT INDICATOR LABEL
K953122 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 637d
Cleared Apr 02, 1997
PRIMARY IV SET
K964435 · FMG
Icu Medical, Inc.
General Hospital · 148d
Cleared Apr 02, 1997
BECTON DICKINSON BLUNT PLASTIC CANNULA
K964654 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 133d
Cleared Apr 02, 1997
CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)
K964989 · LHI
Critical Device Corp.
General Hospital · 110d
Cleared Apr 02, 1997
ALEXANDER MANUFACTURING COMPANY
K970271 · FLL
Alexander Mfg. Co.
General Hospital · 69d
Cleared Apr 02, 1997
INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
K970438 · FPA
Baxter Healthcare Corp
General Hospital · 56d
Cleared Apr 02, 1997
MAXCESS NEEDLEFREE - Y- SITE (100713)
K970800 · FPA
Solopak Medical Products, Inc.
General Hospital · 29d
Cleared Apr 01, 1997
ONCE-A-DAY BOWIE AND DICK TEST PACK.
K961156 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 375d
Cleared Apr 01, 1997
NEO-PICC
K970434 · LJS
Klein-Baker Medical, Inc.
General Hospital · 55d
Cleared Apr 01, 1997
REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE
K970924 · KGO
Regent Medical
General Hospital · 25d
Cleared Mar 31, 1997
INTRAVIA CONTAINER, EMPTY
K964853 · KPE
Baxter Healthcare Corp
General Hospital · 118d
Cleared Mar 31, 1997
MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
K970479 · KZH
Medtronic Minimed
General Hospital · 52d
Cleared Mar 31, 1997
EYE TRAY
K970722 · KKX
Trinity Laboratories, Inc.
General Hospital · 32d
Cleared Mar 28, 1997
B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE
K970737 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 28d
Cleared Mar 27, 1997
POINT OF USE II SHARPS-A-GATOR
K964387 · MMK
Graphic Controls Corp.
General Hospital · 143d
Cleared Mar 27, 1997
NIPRO DISPOSABLE SOLUTION INFUSION SET
K970076 · FPA
Nipro Medical Corp.
General Hospital · 77d