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
5785–5808 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 24, 2006
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K062665 · MSH
Inovel, LLC
General Hospital · 47d
Cleared Oct 24, 2006
KOZY COMFORT INFANT POSITIONER
K062143 · FRP
Alfred E Mann Inst. For Biomedical...
General Hospital · 89d
Cleared Oct 24, 2006
OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS
K060971 · MEG
Omi Manufacturing Pty., Ltd.
General Hospital · 200d
Cleared Oct 20, 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED)
K062882 · LYZ
Suqian Green Glove Co., Ltd.
General Hospital · 24d
Cleared Oct 18, 2006
STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
K061661 · MEB
Advanced Infusion, Inc.
General Hospital · 127d
Cleared Oct 18, 2006
TORBOT VASCULAR COMPRESSION GARMENTS
K061411 · DWL
Torbut Group, Inc.
General Hospital · 149d
Cleared Oct 16, 2006
MANUEL SAFTEY SYRINGE PARTS 1 & 2
K060772 · MEG
Medsafe Asa
General Hospital · 208d
Cleared Oct 16, 2006
CONMED LINVATEC INSTRUMENT STERILIZATION TRAY
K052992 · FRG
Conmed Linvatec
General Hospital · 356d
Cleared Oct 12, 2006
MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI...
K060458 · FEB
Langford IC Systems, Inc.
General Hospital · 232d
Cleared Oct 11, 2006
MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS
K062663 · MSH
Moldex/Metric, Inc.
General Hospital · 34d
Cleared Oct 11, 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES
K062520 · LYZ
Jiangsu Jaysun Glove Co., Ltd.
General Hospital · 44d
Cleared Oct 06, 2006
MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
K062302 · KDQ
Millicore AB
General Hospital · 59d
Cleared Oct 05, 2006
POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE
K062138 · LZA
Molnlycke Health Care, Inc.
General Hospital · 71d
Cleared Sep 29, 2006
ARTHREX ASPIRATE KIT
K062365 · FMF
Arthrex, Inc.
General Hospital · 46d
Cleared Sep 29, 2006
TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233
K061942 · FLL
Ge Healthcare
General Hospital · 81d
Cleared Sep 29, 2006
MULTICATH EXPERT
K061250 · FOZ
Vygon Corp.
General Hospital · 148d
Cleared Sep 29, 2006
INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200
K052870 · NZP
Kimberly-Clark Corp.
General Hospital · 353d
Cleared Sep 28, 2006
V-2200 INFANT INCUBATOR
K061856 · FMZ
Atom Medical, Inc.
General Hospital · 90d
Cleared Sep 25, 2006
SURGICAL DRAPES
K061422 · KKX
Austin Medical, Inc.
General Hospital · 125d
Cleared Sep 21, 2006
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
K062457 · MEB
Baxter Healthcare Corporation
General Hospital · 29d
Cleared Sep 20, 2006
LYRA ACUPUNCTURE NEEDLES
K062448 · MQX
Helio Medical Supplies, Inc.
General Hospital · 29d
Cleared Sep 18, 2006
POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
K062655 · LYZ
Shijiazhuang Junfei Plastic Products...
General Hospital · 11d
Cleared Sep 15, 2006
29G AND 30G K-PACK II NEEDLE
K062608 · FMI
Terumo Europe N.V.
General Hospital · 10d
Cleared Sep 15, 2006
LIFECATH S PICC AND MIDLINE CATHETER
K062425 · LJS
Vygon Corp.
General Hospital · 28d