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
5521–5544 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 05, 2007
VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK
K070895 · JOJ
STERIS Corporation
General Hospital · 159d
Cleared Sep 04, 2007
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K072085 · LYZ
Zibo Hongye Shangqin Plastic Rubbert...
General Hospital · 36d
Cleared Sep 04, 2007
DANA 3CC SYRINGE INSULIN RESERVOIR
K071418 · MRZ
Sooil Development Co., Ltd.
General Hospital · 105d
Cleared Aug 31, 2007
MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
K072108 · FLL
Tecnimed S.R.L.
General Hospital · 30d
Cleared Aug 31, 2007
HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION...
K070630 · FPA
Health Line International Corporation...
General Hospital · 177d
Cleared Aug 31, 2007
OPACIDEN OPA REAGENT STRIPS
K070419 · JOJ
Hach Company
General Hospital · 199d
Cleared Aug 30, 2007
MODIFICATION TO EZ HUBER SAFETY INFUSION SET
K071846 · FPA
Pfm Medical, Inc.
General Hospital · 56d
Cleared Aug 30, 2007
ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS...
K071538 · FOZ
Arrow International, Inc.
General Hospital · 86d
Cleared Aug 30, 2007
SHANGHAI CHINA STAR CORP. POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE
K071072 · LZA
Shanghai China Star Corp
General Hospital · 136d
Cleared Aug 27, 2007
ANGIODYNAMICS, INC MORPHEUS PICC AND PROCEDURE KIT
K072196 · LJS
AngioDynamics, Inc.
General Hospital · 20d
Cleared Aug 27, 2007
MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE...
K072157 · FMT
Ohmeda Medical
General Hospital · 24d
Cleared Aug 23, 2007
SC PROFI FINE PEN NEEDLE, MODELS
K070988 · FMI
Shinchang Medical Co., Ltd.
General Hospital · 139d
Cleared Aug 23, 2007
SMALL VOLUME SYRINGE
K062865 · FMF
Alcon Laboratories
General Hospital · 332d
Cleared Aug 22, 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES
K071686 · LYZ
Langfang Huilong Plastic Product Co.,...
General Hospital · 63d
Cleared Aug 20, 2007
R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001,...
K071361 · LJS
R4 Vascular, Inc.
General Hospital · 97d
Cleared Aug 17, 2007
BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER
K070002 · LJS
Boston Scientific
General Hospital · 226d
Cleared Aug 16, 2007
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
K071459 · FMF
B.Braun Medical, Inc.
General Hospital · 83d
Cleared Aug 16, 2007
CRYOSEAL FS APPLICATOR SYSTEM
K071126 · FMF
Thermogenesis Corp.
General Hospital · 115d
Cleared Aug 16, 2007
COMCASET-P SAFETY IV CATHETER
K070020 · FOZ
Pitango Medical, Ltd.
General Hospital · 225d
Cleared Aug 15, 2007
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K072001 · LYZ
Tangshan Hongyun Plastic Products...
General Hospital · 23d
Cleared Aug 15, 2007
HEATMARKER TIME TEMPERATURE INDICATOR
K063759 · OCI
Temptime Corporation
General Hospital · 239d
Cleared Aug 10, 2007
STD MED PRIMO PORT
K070911 · LJT
Std Med, Inc.
General Hospital · 130d
Cleared Aug 08, 2007
CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML
K072037 · MEG
Life-Shield Products, Inc.
General Hospital · 14d
Cleared Aug 07, 2007
MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES
K071207 · LZA
High Momentum Sdn Bhd
General Hospital · 98d