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
5881–5904 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 06, 2006
K-SHIELD PORT ACCESS INFUSION SET
K060580 · FPA
Kawasumi Laboratories, Inc.
General Hospital · 92d
Cleared Jun 06, 2006
CONFIDOSE IM AUTO-INJECTOR
K060389 · KZH
Pharma-Pen, Inc.
General Hospital · 112d
Cleared Jun 06, 2006
SERVICE MANAGER SM40SE
K053464 · FYD
Conmed Integrated Systems, Canada, Ulc
General Hospital · 175d
Cleared Jun 06, 2006
CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C
K052798 · LGN
Isovac Products, LLC
General Hospital · 246d
Cleared Jun 05, 2006
OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
K061426 · CAH
Porous Media Corp.
General Hospital · 13d
Cleared Jun 05, 2006
TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND...
K061308 · FYA
Cardinal Health 200, Inc.
General Hospital · 26d
Cleared Jun 02, 2006
SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES
K061240 · LJS
Lucent Medical Systems
General Hospital · 30d
Cleared Jun 02, 2006
RITRACT SAFETY SYRINGE
K060002 · MEG
Ritract , Ltd.
General Hospital · 150d
Cleared Jun 02, 2006
SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE
K053305 · LYY
Pt Mahakarya Inti Buana
General Hospital · 186d
Cleared Jun 01, 2006
CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093
K061183 · FMF
Confluent Surgical,Inc
General Hospital · 34d
Cleared May 31, 2006
HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS
K060352 · FPA
Health Line International Corporation
General Hospital · 107d
Cleared May 31, 2006
MICROTEK MEDICAL WARMING DRAPE
K060200 · KKX
Microtek Medical, Inc.
General Hospital · 125d
Cleared May 30, 2006
AUTOFUSER
K060258 · MEB
Ace Medical Us, LLC
General Hospital · 118d
Cleared May 25, 2006
SURGICAL FACE MASK
K060776 · FXX
Hong YA Non-Woven Products Co., Ltd.
General Hospital · 64d
Cleared May 25, 2006
POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH GLYCERINE...
K060726 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 69d
Cleared May 24, 2006
ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
K061074 · LZA
Bright Element Sdn Bhd
General Hospital · 37d
Cleared May 24, 2006
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K060909 · LYZ
Jiangsu Everyguard Plastic Products...
General Hospital · 51d
Cleared May 23, 2006
BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE COPOLYMER...
K061192 · LZA
Ethicon Endo-Surgery, LLC
General Hospital · 25d
Cleared May 22, 2006
MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
K061128 · FRN
Medrad, Inc.
General Hospital · 28d
Cleared May 22, 2006
GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000
K060649 · FLL
Tyco Healthcare Group LP
General Hospital · 70d
Cleared May 19, 2006
BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
K061078 · LYY
Bright Element Sdn Bhd
General Hospital · 32d
Cleared May 19, 2006
K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-2100
K060240 · FLL
K-Jump Health Co., Ltd.
General Hospital · 108d
Cleared May 17, 2006
HAEMONETICS 40U RBC FILTER BAG
K061103 · CAK
Haemonetics Corp.
General Hospital · 27d
Cleared May 17, 2006
POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)
K060724 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 61d