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
6097–6120 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 09, 2005
TRU-SWAB STOCOCK
K052330 · FMG
Medegen Medical Manufacturing Services
General Hospital · 14d
Cleared Sep 09, 2005
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP)
K052117 · MEB
I-Flow Corp.
General Hospital · 36d
Cleared Sep 09, 2005
RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES
K051269 · FLL
Radiant Innovation, Inc.
General Hospital · 115d
Cleared Sep 07, 2005
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
K051279 · BZK
Caldyne, Inc.
General Hospital · 113d
Cleared Sep 07, 2005
INFRARED EAR THEMOMETER, MODELS DX6603, DX66390
K051251 · FLL
Shenzhen Dongdixin Technology Co., Ltd.
General Hospital · 114d
Cleared Sep 02, 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW)
K051924 · LYZ
Shijiazhuang Manful Light Industrial...
General Hospital · 49d
Cleared Sep 02, 2005
YI XIN STERILE SYRINGE FOR SINGLE USE
K050999 · FMF
Jiangxi Sanxin (Eversincere) Medical...
General Hospital · 135d
Cleared Sep 01, 2005
NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX...
K052016 · LYY
Sgmp Co., Ltd.
General Hospital · 37d
Cleared Sep 01, 2005
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K051669 · LHI
Migada Plant
General Hospital · 71d
Cleared Sep 01, 2005
DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE
K051422 · FLL
Medisim, Ltd.
General Hospital · 92d
Cleared Sep 01, 2005
COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
K051264 · FPA
Unomedical A/S
General Hospital · 108d
Cleared Sep 01, 2005
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS
K051157 · KCT
Micromedics, Inc.
General Hospital · 119d
Cleared Aug 26, 2005
NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
K051574 · FMF
Nipro Medical Corp.
General Hospital · 73d
Cleared Aug 26, 2005
FIBRIN ANALYSIS SYSTEM ENDOLUMINAL BRUSH
K050889 · LJS
Crs Medical Diagnostics, Inc.
General Hospital · 142d
Cleared Aug 24, 2005
HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP...
K052052 · FRN
Hospira, Inc.
General Hospital · 26d
Cleared Aug 23, 2005
VITALCARE I.V. ADMINISTRATION SET
K050906 · FPA
Vitalcare Group, Inc.
General Hospital · 134d
Cleared Aug 19, 2005
VYGON NUTRILINE CATHETERS
K051690 · LJS
Vygon Corp.
General Hospital · 57d
Cleared Aug 19, 2005
STERRAD STERILIZER CYCLESURE TEST PACK
K051643 · FRC
Advanced Sterilization Products
General Hospital · 60d
Cleared Aug 18, 2005
CS MEDICAL TD-100 TRANSESOPHAGEAL PROBE DISINFECTOR, MODEL TD-100, CS MEDICAL...
K051305 · PSW
Cs Medical, LLC
General Hospital · 91d
Cleared Aug 17, 2005
BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
K051985 · KZE
Biovalve Technologies, Inc.
General Hospital · 26d
Cleared Aug 17, 2005
ENCORE STERILE POWDER-FREE LATEX SURGICAL GLOVE WITH PROPRIETARY COATING...
K051793 · KGO
Ansell Healthcare Products, LLC
General Hospital · 47d
Cleared Aug 16, 2005
3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER
K052128 · FRC
3M Company
General Hospital · 11d
Cleared Aug 16, 2005
TERUMO SYRINGE WITH/WITHOUT NEEDLE
K052034 · FMF
Terumo Medical Corp.
General Hospital · 19d
Cleared Aug 16, 2005
DRUG ACCESS SPIKE
K051930 · FMF
Medegen Medical Manufacturing Services
General Hospital · 34d