FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,754 results
8833–8856 of 17,754
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 18, 1998
SMARTTEX POWDER FREE LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM
K981347 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 38d
Cleared May 18, 1998
SMARTTEX PREPOWDERED LATEX EXAMINATION GLOVES
K981348 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 38d
Cleared May 18, 1998
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES
K981349 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 38d
Cleared May 15, 1998
COVERTIP SAFETY SYRINGE
K971077 · MEG
Medisys Technologies, Inc.
General Hospital · 417d
Cleared May 15, 1998
THE SYSTEM 2S STEAM STERILIZER
K980014 · FLE
STERIS Corporation
General Hospital · 133d
Cleared May 15, 1998
VARIOUS SURGICAL OR PATIENT DRAPES
K980210 · KKX
Gel-Lite, LLC
General Hospital · 114d
Cleared May 15, 1998
MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK
K981073 · FYA
Medcom Laundry Service, Inc.
General Hospital · 52d
Cleared May 15, 1998
LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES
K981179 · LZA
Lovytex Sdn Bhd
General Hospital · 44d
Cleared May 11, 1998
MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP...
K973561 · FOZ
Medical Components, Inc.
General Hospital · 234d
Cleared May 11, 1998
C/T MED-SYSTEMS CASSETTE SYSTEM
K980065 · KCT
C/T Med System, Ltd.
General Hospital · 124d
Cleared May 11, 1998
REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE
K980942 · KGO
London International Group, Inc.
General Hospital · 60d
Cleared May 11, 1998
ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
K981392 · KGO
Ansell Perry
General Hospital · 24d
Cleared May 07, 1998
QUICK CHECK INSTANT THERMOMETER
K971831 · FLL
Ejb Medical, Inc.
General Hospital · 356d
Cleared May 07, 1998
TRIMPORT
K974533 · LJT
Gerard Medical, Inc.
General Hospital · 156d
Cleared May 05, 1998
EXEL AVF SINGLE NEEDLE
K963658 · FMI
Exel Intl.
General Hospital · 609d
Cleared May 04, 1998
LATEX FINGER COT, POWDER-FREE, WITH PROTEIN LABELING
K980827 · LZB
Tucker & Associates
General Hospital · 62d
Cleared May 01, 1998
GLASS VAN GLASS SYRINGES
K963364 · FMF
Myco Medical Supplies, Inc.
General Hospital · 613d
Cleared May 01, 1998
B-D ASSURE EAR THERMOMETER
K971994 · FLL
Becton Dickinson Consumer Products
General Hospital · 337d
Cleared May 01, 1998
HEELBO WAIST AND CHEST VEST
K980640 · FMQ
Heelbo, Inc.
General Hospital · 71d
Cleared May 01, 1998
PASV DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL NUMBER...
K981368 · FOZ
Catheter Innovations, Inc.
General Hospital · 16d
Cleared May 01, 1998
PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER...
K981382 · FOZ
Catheter Innovations, Inc.
General Hospital · 15d
Cleared Apr 30, 1998
RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC
K972705 · FMI
Sage Products, Inc.
General Hospital · 283d
Cleared Apr 30, 1998
KLEENASEPTIC
K981023 · LRJ
Metrex Research Corp.
General Hospital · 42d
Cleared Apr 28, 1998
I.V. CATHETER SYSTEM
K980493 · FOZ
Johnson & Johnson Medical, Inc.
General Hospital · 78d