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
5329–5352 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 20, 2008
OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500
K081094 · MEC
Olympic Medical Corp.
General Hospital · 64d
Cleared Jun 19, 2008
MICRO-TOUCH NITRAFREE
K080536 · LZA
Ansell Healthcare Products, LLC
General Hospital · 113d
Cleared Jun 18, 2008
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM
K072602 · FMI
Medpro Safety Products, Inc.
General Hospital · 278d
Cleared Jun 13, 2008
SWC/DWC WARMING CABINETS
K080609 · LHC
Mac Medical
General Hospital · 102d
Cleared Jun 11, 2008
BROWNE OPA TEST STRIP
K081427 · JOJ
STERIS Corporation
General Hospital · 21d
Cleared Jun 06, 2008
AVIATOR TRANSPORT INCUBATOR
K081399 · FPL
International Biomedical, Ltd.
General Hospital · 18d
Cleared Jun 06, 2008
NILIMEDIX ADI
K070844 · LZG
Nilimedix , Ltd.
General Hospital · 437d
Cleared Jun 04, 2008
POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
K081311 · LJT
C.R. Bard, Inc.
General Hospital · 26d
Cleared Jun 04, 2008
FEEL-FINE INSULIN PEN NEEDLE
K080904 · FMI
Feel Tech
General Hospital · 64d
Cleared Jun 03, 2008
ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINER
K081449 · MMK
Ultimed, Inc.
General Hospital · 11d
Cleared Jun 02, 2008
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION...
K072080 · LGZ
Smiths Medical Asd, Inc.
General Hospital · 308d
Cleared May 30, 2008
TSO3 OZONE STERILIZATION WRAP
K080198 · FRG
Tso3, Inc.
General Hospital · 126d
Cleared May 30, 2008
MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY
K073051 · FRN
Medrad, Inc.
General Hospital · 214d
Cleared May 28, 2008
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION...
K073244 · FRC
STERIS Corporation
General Hospital · 191d
Cleared May 27, 2008
WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H
K081256 · FLL
Rio Flexon Technology Co., Ltd.
General Hospital · 25d
Cleared May 23, 2008
POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE
K080937 · LZA
Gx Corporation Sdn Bhd
General Hospital · 51d
Cleared May 23, 2008
TARRY MEDICAL TEMPERATURE PROBES
K071977 · FMZ
Tarry Medical Products, Inc.
General Hospital · 311d
Cleared May 22, 2008
SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL
K073684 · KMJ
Sheffield Industries, Div. of Faria ,...
General Hospital · 146d
Cleared May 21, 2008
SMITH & NEPHEW INSTRUMENT TRAYS
K073551 · KCT
Smith & Nephew Inc., Endoscopy Div.
General Hospital · 155d
Cleared May 20, 2008
POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE
K081040 · LYY
Pt.Shamrock Manufacturing Corp.
General Hospital · 39d
Cleared May 16, 2008
T34L SYRINGE DRIVER
K080954 · FRN
Caesarea Medical Electronics , Ltd.
General Hospital · 43d
Cleared May 16, 2008
POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH...
K072300 · LYY
Perusahaan Pelindung Getah (M) Sdn Bhd
General Hospital · 273d
Cleared May 15, 2008
EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE
K080587 · MRZ
Animas Corp.
General Hospital · 73d
Cleared May 15, 2008
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
K080227 · MRZ
Roche Diagnostics Corp.
General Hospital · 106d