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
6145–6168 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 22, 2005
VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)
K051662 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 30d
Cleared Jul 22, 2005
NITRILE EXAMINATION GLOVES, POWDER FREE
K051333 · LZA
Shun Thai Rubber Gloves Industry Co.,...
General Hospital · 60d
Cleared Jul 21, 2005
TURBO-FLO PICC
K041849 · LJS
Cook, Inc.
General Hospital · 378d
Cleared Jul 19, 2005
STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN...
K051329 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 60d
Cleared Jul 15, 2005
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW)
K051723 · LYZ
Zibo Sinocare Plastic Products Co., Ltd.
General Hospital · 18d
Cleared Jul 15, 2005
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE...
K051253 · MEA
Baxter Healthcare Corp
General Hospital · 60d
Cleared Jul 14, 2005
BARRIER SURGICAL DRAPES
K051625 · KKX
Molnlycke Health Care, Inc.
General Hospital · 24d
Cleared Jul 13, 2005
ANGIODYNAMICS TUMESCENT INFUSION DEVICE
K051142 · FPA
AngioDynamics, Inc.
General Hospital · 70d
Cleared Jul 13, 2005
TISSU-TRANS
K050797 · KYZ
Shippert Medical Technologies Corp.
General Hospital · 106d
Cleared Jul 12, 2005
POWDERED LATEX PATIENT EXAMINATION GLOVES
K051465 · LYY
P.T. Anlis Abadi Internasional
General Hospital · 39d
Cleared Jul 12, 2005
HUBER CLEAR SAFETY INFUSION SET
K051009 · FPA
Now Medical Distribution, Inc.
General Hospital · 82d
Cleared Jul 12, 2005
POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
K050968 · LZA
Pt. Medisafe Technologies
General Hospital · 85d
Cleared Jul 07, 2005
POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT SCENTED (BLUE COLOR)
K051372 · LZA
Platinum Glove Industries Sdn. Bhd.
General Hospital · 42d
Cleared Jul 06, 2005
DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR
K051498 · LYZ
Ever Global Enterprise Corporation
General Hospital · 29d
Cleared Jul 01, 2005
SYMBIOS DISPOSABLE INFUSION PUMP KIT
K051474 · MEB
Symbios Medical Products, LLC
General Hospital · 28d
Cleared Jul 01, 2005
COMPEL 1-PLY SURGICAL GOWNS
K041653 · FYA
Standard Textile Co., Inc.
General Hospital · 379d
Cleared Jun 30, 2005
6 FR FL POWERHOHN AND POWERLINE CATHETER
K051417 · LJS
C.R. Bard, Inc.
General Hospital · 29d
Cleared Jun 30, 2005
PENTATRASFU BLOOD TRANSFUSION SETS
K041496 · BRZ
Pentaferte S.P.A
General Hospital · 391d
Cleared Jun 29, 2005
AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE
K050953 · CAH
Air Safety, Ltd.
General Hospital · 75d
Cleared Jun 24, 2005
SHL DISPOSABLE AUTOINJECTOR
K050434 · KZH
Shl Medical, USA
General Hospital · 122d
Cleared Jun 23, 2005
COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE,...
K051345 · LYY
Glovco (M) Sdn. Bhd.
General Hospital · 31d
Cleared Jun 22, 2005
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
K051499 · FPA
Medegen Medical Manufacturing Services
General Hospital · 15d
Cleared Jun 21, 2005
OMRON MODEL 514N TYMPANIC THERMOMETER
K051233 · FLL
Omron Healthcare, Inc.
General Hospital · 39d
Cleared Jun 21, 2005
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K051148 · LYZ
Zibo Sinocare Plastic Products Co., Ltd.
General Hospital · 48d