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
9961–9984 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 29, 1996
SHARPSPRO-TECTOR
K942073 · FMI
Superior Diapering Products , Ltd.
General Hospital · 671d
Cleared Feb 28, 1996
PUMP/BLOOD CHEMISTRY MONITOR
K951739 · LZF
Via Medical Corp.
General Hospital · 320d
Cleared Feb 27, 1996
G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
K960204 · FRG
GE Medical Systems
General Hospital · 42d
Cleared Feb 27, 1996
CPR LACERATION TRAY
K960207 · FRG
Custom Pack Reliability
General Hospital · 42d
Cleared Feb 26, 1996
ANGIOFLUSH II FLUID MANAGEMENT SYSTEM
K953825 · FPA
AngioDynamics, Inc.
General Hospital · 195d
Cleared Feb 22, 1996
ATI ETHYLENE OXIDE STERILIZATION INDICATOR
K952995 · JOJ
Pymah Corp.
General Hospital · 239d
Cleared Feb 22, 1996
POLYFIN QR SUBCUTANEOUS INFUSION SET
K954969 · FPA
Medtronic Minimed
General Hospital · 115d
Cleared Feb 21, 1996
RNS STERILE DISPOSABLE PUNCTURE TRAY
K955678 · FRG
Contour Fabricators of Florida, Inc.
General Hospital · 69d
Cleared Feb 21, 1996
RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
K955686 · FRG
Contour Fabricators of Florida, Inc.
General Hospital · 69d
Cleared Feb 21, 1996
RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY
K955688 · FRG
Contour Fabricators of Florida, Inc.
General Hospital · 69d
Cleared Feb 21, 1996
WINGED & SUBCUTANEOUS INFUSION SETS
K955709 · FPA
Distronic Sterile Products, Inc.
General Hospital · 65d
Cleared Feb 21, 1996
VENTED SOLUTION SET
K955732 · FPA
Distronic Sterile Products, Inc.
General Hospital · 64d
Cleared Feb 21, 1996
MED-NET STOPCOCKS
K955782 · FMG
Mednet, Inc.
General Hospital · 62d
Cleared Feb 21, 1996
G.E. STERILE, STANDARD BIOPSY TRAY
K960141 · FRG
GE Medical Systems
General Hospital · 36d
Cleared Feb 21, 1996
G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY
K960201 · FRG
GE Medical Systems
General Hospital · 36d
Cleared Feb 21, 1996
G.E. STERILE PUNCTURE TRAY
K960202 · FRG
GE Medical Systems
General Hospital · 36d
Cleared Feb 16, 1996
UNIQUE NEEDLE WITH FIRM GRIP SHIELD
K950666 · FMF
Unique Management Ent., Inc.
General Hospital · 368d
Cleared Feb 16, 1996
NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET
K952852 · FPA
Critical Device Corp.
General Hospital · 240d
Cleared Feb 13, 1996
INSULCAP
K952044 · FMI
Karen Holtz
General Hospital · 288d
Cleared Feb 13, 1996
MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM
K960013 · FOZ
MDC Research , Ltd.
General Hospital · 42d
Cleared Feb 12, 1996
B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE
K955235 · FMI
Bd Becton Dickinson Vacutainer...
General Hospital · 90d
Cleared Feb 12, 1996
PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS
K955407 · LJT
Sims Deltec, Inc.
General Hospital · 77d
Cleared Feb 12, 1996
ALPHA MICRON 20 MICROAGGREGATE FILTER
K955515 · CAK
Alpha Therapeutic Corp.
General Hospital · 70d
Cleared Feb 09, 1996
UNIMED MEDICAL DISPENSING PUMP
K952967 · FRN
A.Z.E. Medical, Inc.
General Hospital · 227d