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
10393–10416 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 23, 1995
CATCO THORACIC CATHETER
K945728 · JOL
Catco Medical, Inc.
General Hospital · 182d
Cleared May 23, 1995
SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR
K950284 · FOZ
Sims Deltec, Inc.
General Hospital · 119d
Cleared May 23, 1995
MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER
K951515 · FMI
Sherwood Medical Co.
General Hospital · 50d
Cleared May 22, 1995
PRIMA FILTER
K952015 · CAH
Prima, Inc.
General Hospital · 24d
Cleared May 19, 1995
I.V. FILTER SET
K933523 · FPB
Mediziv Medical Products 1987 , Ltd.
General Hospital · 668d
Cleared May 19, 1995
LF CT HIG PRESSURE CATHETERS
K945053 · FOZ
Mallinckrodt Group, Inc.
General Hospital · 217d
Cleared May 19, 1995
STERILE EMPTY PCA SYRINGE
K945797 · FMF
Intl. Medication Systems, Ltd.
General Hospital · 172d
Cleared May 19, 1995
STERRAD STERILIZATION POUCH
K951295 · KCT
Advanced Sterilization Products
General Hospital · 58d
Cleared May 19, 1995
STRATO/INFUSAIND MICROPORT VASCULAR ACC. SYSTEM
K951873 · LJT
Strato/Infusaid, Inc.
General Hospital · 28d
Cleared May 19, 1995
STRATO/INFUSAID MACROPORT VASCULAR ACC. SYSTEM
K951874 · LJT
Strato/Infusaid, Inc.
General Hospital · 28d
Cleared May 18, 1995
MEDICAL SUPPORT STOCKINGS
K951234 · DWL
Jobst A Beiersdorf Co.
General Hospital · 59d
Cleared May 18, 1995
STRATO/INFUSAID DUALPORT VASCULAR ACC. SYSTEM
K951872 · LJT
Strato/Infusaid, Inc.
General Hospital · 27d
Cleared May 17, 1995
DI ISOLATION GOWN
K942351 · FYC
Derekduck Industries Corp.
General Hospital · 365d
Cleared May 17, 1995
COMFIT (PINK)
K943601 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 296d
Cleared May 17, 1995
VANGUARD
K946084 · FMI
Vanguard Container Corp.
General Hospital · 155d
Cleared May 17, 1995
ASSURE, SELF-SEALING STERILIZATION POUCH
K951590 · KCT
Sultan Chemists, Inc.
General Hospital · 41d
Cleared May 17, 1995
PROFEEL
K951661 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 37d
Cleared May 17, 1995
COMFIT/BEADED SURGEON'S GLOVE
K951662 · KGO
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 37d
Cleared May 17, 1995
COMFIT/GREEN POWDERED EXAMINATION GLOVES
K951667 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 37d
Cleared May 17, 1995
SCIPOTEX/POWDER FREE EXAMINATION GLOVES
K951668 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 37d
Cleared May 16, 1995
TS1 TURTLE(TM) SYRINGE
K936225 · MEG
Kershenstine Diamond, Inc.
General Hospital · 512d
Cleared May 16, 1995
STERILE EQUIPMENT COVER
K951214 · KKX
Gulfstream Medical
General Hospital · 60d
Cleared May 12, 1995
ALL-IN-ONE TWO CHAMBER CONTAINER
K945193 · KPE
Baxter Healthcare Corp
General Hospital · 200d
Cleared May 11, 1995
B-D ULTRA-FINE II PEN NEEDLE
K950466 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 97d