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
9889–9912 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 23, 1996
FREE FLOW SAFETY DEVICE
K954883 · FPA
Migada, Inc.
General Hospital · 186d
Cleared Apr 22, 1996
5 FR PICC-LINE CATHETER
K954638 · LJS
Vygon Corp.
General Hospital · 199d
Cleared Apr 22, 1996
STOPCOCK & LUER LOCK PLUG
K954970 · FMG
Medex, Inc.
General Hospital · 175d
Cleared Apr 22, 1996
SURGICAL MASK (NON-STERILE)
K955513 · FXX
United Medical Ent., Inc.
General Hospital · 140d
Cleared Apr 22, 1996
PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
K960993 · CAK
Pall Biomedical Products Co.
General Hospital · 41d
Cleared Apr 18, 1996
UNIVEC NON-REUSABLE SYRINGE
K933469 · MEG
Univec, Inc.
General Hospital · 1007d
Cleared Apr 18, 1996
SURGICAL APPAREL
K954549 · FYC
Global Healthcare, Inc.
General Hospital · 199d
Cleared Apr 17, 1996
CELSITE PEDIATRIC VENOUS SYSTEM
K952435 · LJT
B.Braun Medical, Inc.
General Hospital · 329d
Cleared Apr 17, 1996
MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY...
K960285 · KZE
Medi-Ject Corp.
General Hospital · 89d
Cleared Apr 17, 1996
CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE
K960921 · LHI
Codan Medlon, Inc.
General Hospital · 42d
Cleared Apr 17, 1996
AREMA II
K961129 · FNM
Mellen Air Mfg., Inc.
General Hospital · 27d
Cleared Apr 15, 1996
ENTERALITE
K954735 · LZH
Zevex Intl., Inc.
General Hospital · 182d
Cleared Apr 15, 1996
GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES
K954967 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 168d
Cleared Apr 15, 1996
POWDER FREE TACTYLON SURGEONS GLOVE
K955419 · KGO
Tactyl Technologies, Inc.
General Hospital · 140d
Cleared Apr 15, 1996
CPR SUCTION CATHETER KIT
K960216 · JOL
Custom Pack Reliability
General Hospital · 90d
Cleared Apr 15, 1996
THERAPORT VASCULAR ACCESS SYSTEM
K960350 · LJT
Biocontrol Technology, Inc.
General Hospital · 81d
Cleared Apr 15, 1996
NON-CORING NEEDLE
K960698 · FMI
Med Institute, Inc.
General Hospital · 55d
Cleared Apr 15, 1996
CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING
K961177 · DWL
Carolina Narrow Fabric Co.
General Hospital · 21d
Cleared Apr 12, 1996
CPR DRESSING CHANGE TRAY
K960206 · FRG
Custom Pack Reliability
General Hospital · 87d
Cleared Apr 12, 1996
CPR ORTHO HAND PACK
K960210 · FRG
Custom Pack Reliability
General Hospital · 87d
Cleared Apr 12, 1996
CPR TOTAL KNEE PACK
K960211 · FRG
Custom Pack Reliability
General Hospital · 87d
Cleared Apr 12, 1996
CPR TOTAL HIP PACK
K960213 · FRG
Custom Pack Reliability
General Hospital · 87d
Cleared Apr 12, 1996
GENERAL PROCEDURE KIT
K960248 · FMF
Physician Industries, Inc.
General Hospital · 87d
Cleared Apr 04, 1996
MIDMARK MIDLINE CATHETER
K951620 · FOZ
Menlo Care, Inc.
General Hospital · 363d