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
9241–9264 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 25, 1997
PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905
K972123 · FMQ
Smith
General Hospital · 50d
Cleared Jul 24, 1997
CORELIFE
K964230 · FMF
Core Healthcare , Ltd.
General Hospital · 274d
Cleared Jul 24, 1997
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
K971742 · FMQ
Depuy, Inc.
General Hospital · 73d
Cleared Jul 24, 1997
PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.
K972338 · FMQ
Geriatric Products, Inc.
General Hospital · 31d
Cleared Jul 24, 1997
RAMY INTEGRATED NEEDLE SYRINGE
K972452 · FMF
Alshifa Medical Syringes Mfg. Co., Ltd.
General Hospital · 78d
Cleared Jul 23, 1997
FENWAL 40 MICRON TRANSFUSION FILTER
K972159 · CAK
Baxter Healthcare Corp
General Hospital · 44d
Cleared Jul 18, 1997
MODIFIED PEDIKAIR
K954320 · FNM
Kinetic Concepts, Inc.
General Hospital · 680d
Cleared Jul 18, 1997
STERILE AMBULATORY RESERVOIR 60ML/100ML
K962159 · MRZ
Faulding Medical Device Co.
General Hospital · 409d
Cleared Jul 18, 1997
PULSE*SPRAY INJECTOR
K963574 · FRN
AngioDynamics, Inc.
General Hospital · 315d
Cleared Jul 18, 1997
ISOLYSER SDS SHARPS CONTAINER
K970547 · FMI
Thantex Specialties, Inc.
General Hospital · 156d
Cleared Jul 18, 1997
REST MATTRESS
K971568 · FNM
Rest Mattress
General Hospital · 80d
Cleared Jul 16, 1997
NEEDLE-FREE VALVED CONNECTOR AND CAP
K964439 · FPA
Bmw Medical, Inc.
General Hospital · 252d
Cleared Jul 16, 1997
SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT...
K971461 · FMT
Fisher & Paykel Electronics , Ltd.
General Hospital · 86d
Cleared Jul 15, 1997
UNIJECT SURGICAL GLOVES
K970160 · KGO
Uniject Gloves , Ltd.
General Hospital · 180d
Cleared Jul 15, 1997
ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE
K971168 · MEB
Baxter Healthcare Corp
General Hospital · 106d
Cleared Jul 14, 1997
GANTEX MODEL NSG-75PF
K962539 · KGO
American Pro Latex, Inc.
General Hospital · 381d
Cleared Jul 14, 1997
LATEX EXAMINATION GLOVES
K970770 · LYY
Oon Corp. Resources
General Hospital · 133d
Cleared Jul 14, 1997
PROVEST-PROTECTIVE RESTRAINT
K971561 · FMQ
Jemm Medical Products
General Hospital · 76d
Cleared Jul 14, 1997
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE
K971945 · KGO
Tillotson Healthcare Corp.
General Hospital · 48d
Cleared Jul 10, 1997
FAR-EAST BOUFFANT CAPS
K970988 · LYU
Far East Science & Technology...
General Hospital · 114d
Cleared Jul 10, 1997
FAR-EAST SHOE COVERS
K971191 · FXP
Far East Science & Technology...
General Hospital · 101d
Cleared Jul 10, 1997
SOMA 900 TRANSPORT BED
K971546 · FNL
Nova Technologies, Inc.
General Hospital · 73d
Cleared Jul 10, 1997
PRO CHECK DIGITAL PACIFIER THERMOMETER
K972259 · FLL
Micro Weiss Electronics
General Hospital · 23d
Cleared Jul 09, 1997
ESCORT II CLINICAL THERMOMETRY MODULE (CTM)
K970011 · FLL
Medical Data Electronics
General Hospital · 188d