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
8113–8136 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 24, 2000
E.N.S.I. SYRINGE
K000572 · MEG
Tri-Ject Intl. Corp.
General Hospital · 2d
Cleared Feb 23, 2000
EXEL INJECTION PLUG WITH CAP
K992290 · FPA
Exel Intl.
General Hospital · 231d
Cleared Feb 22, 2000
SYNTHETIC (WHITE) VINAL POWDERED PATIENT EXAMINATION GLOVES
K000166 · LYZ
Shijiazhuang Great Eagle Plastic...
General Hospital · 34d
Cleared Feb 22, 2000
SIMS PORTEX ANESTHESIA CATHETER
K994275 · FRN
Sims Portex, Inc.
General Hospital · 64d
Cleared Feb 18, 2000
SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX...
K000156 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 30d
Cleared Feb 18, 2000
ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH...
K000217 · LYY
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 25d
Cleared Feb 18, 2000
MED-GUARD SURGEON'S GOWN
K992445 · FYA
Kappler USA
General Hospital · 211d
Cleared Feb 18, 2000
PERCUGUARD
K992539 · LZB
Digit-Pro
General Hospital · 203d
Cleared Feb 18, 2000
CONVERTORS SURGICAL GOWNS, STERILE
K994244 · FYA
Allegiance Healthcare Corp.
General Hospital · 64d
Cleared Feb 16, 2000
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT...
K000295 · KGO
Ansell Perry
General Hospital · 16d
Cleared Feb 16, 2000
CASTLE SERIES 100HC STEAM STERILIZERS
K994314 · FLE
Getinge/Castle, Inc.
General Hospital · 56d
Cleared Feb 16, 2000
HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT...
K994432 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 48d
Cleared Feb 14, 2000
NIPRO BLOOD COLLECTION NEEDLE
K992699 · FMI
Nipro Medical Corp.
General Hospital · 186d
Cleared Feb 14, 2000
VEIN ENTRY INDICATOR DEVICE (VEID)
K993995 · FMF
Vascular Technologies , Ltd.
General Hospital · 82d
Cleared Feb 11, 2000
NIPRO INSULIN SYRINGE
K000144 · FMF
Nipro Medical Corp.
General Hospital · 24d
Cleared Feb 10, 2000
PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET...
K000017 · FPA
Rd Medical Mfg., Inc.
General Hospital · 38d
Cleared Feb 10, 2000
GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
K000090 · LYY
Guthrie Medicare Products (Melaka)...
General Hospital · 28d
Cleared Feb 10, 2000
R1000 SERIES INSULIN PUMP
K993184 · LZG
Animas Corp.
General Hospital · 140d
Cleared Feb 10, 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE...
K993918 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 84d
Cleared Feb 10, 2000
HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM
K994196 · LJT
Horizon Medical Products, Inc.
General Hospital · 59d
Cleared Feb 09, 2000
SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
K992979 · LYZ
Shanghai Poseidon Plastic Products...
General Hospital · 159d
Cleared Feb 09, 2000
AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10
K993832 · MEB
Tandem Medical, Inc.
General Hospital · 89d
Cleared Feb 09, 2000
AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK),...
K993912 · LYY
Latexx Partners, Inc.
General Hospital · 84d
Cleared Feb 09, 2000
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING...
K994162 · LYY
Allegiance Healthcare Corp.
General Hospital · 62d