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
6433–6456 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 26, 2004
AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR
K040580 · NRW
D.Y. Instrument, Inc.
General Hospital · 175d
Cleared Aug 24, 2004
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION...
K042081 · FRN
Hospira, Inc.
General Hospital · 21d
Cleared Aug 24, 2004
NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4
K041845 · FPA
Nexus Medical, LLC
General Hospital · 47d
Cleared Aug 23, 2004
SMITH & NEPHEW GRAFT DELIVERY SYSTEM
K041976 · FMF
Smith & Nephew, Inc.
General Hospital · 32d
Cleared Aug 20, 2004
POWDER-FREE BLUE VINYL EXAM GLOVES
K041945 · LYZ
Glormed Intl., Inc.
General Hospital · 32d
Cleared Aug 20, 2004
POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR
K041848 · LZA
Pt. Smartglove Indonesia
General Hospital · 43d
Cleared Aug 20, 2004
SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2
K041436 · KGO
Terang Nusa Sdn Bhd
General Hospital · 84d
Cleared Aug 20, 2004
POWDER-FREE NITRILE EXAMINATION GLOVES
K041276 · LZA
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 100d
Cleared Aug 17, 2004
OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN...
K040108 · LYZ
Est International Corporation
General Hospital · 210d
Cleared Aug 17, 2004
PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST)
K031152 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 494d
Cleared Aug 12, 2004
HOVERJACK AIR PATIENT LIFT DEVICE
K041503 · FNG
D.T. Davis Enterprises , Ltd.
General Hospital · 66d
Cleared Aug 12, 2004
POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)
K040792 · LYY
Pt. Smartglove Indonesia
General Hospital · 136d
Cleared Aug 12, 2004
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING
K033843 · FOZ
Cook, Inc.
General Hospital · 246d
Cleared Aug 12, 2004
PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS...
K032192 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 392d
Cleared Aug 11, 2004
TEGO NEEDLE FREE ACCESS ACCESS DEVICE
K040710 · FPA
Icu Medical, Inc.
General Hospital · 146d
Cleared Aug 09, 2004
VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE
K042028 · LYZ
Zibo Borui Plastic & Rubber Products...
General Hospital · 12d
Cleared Aug 09, 2004
RAVEN PROTEST - STEAM
K041386 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 76d
Cleared Aug 06, 2004
HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01
K041504 · FMF
Haemacure Corp.
General Hospital · 60d
Cleared Aug 05, 2004
CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT
K041691 · LHI
West Pharmaceutical Services, Inc.
General Hospital · 44d
Cleared Aug 04, 2004
EVA TPN CONTAINER
K041415 · KPE
B.Braun Medical, Inc.
General Hospital · 69d
Cleared Aug 03, 2004
NIGHTFORM
K041996 · FRP
Plastic Surgery Solutions, LLC
General Hospital · 8d
Cleared Aug 03, 2004
BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND...
K041970 · MEG
Biotop Technology Co., Ltd.
General Hospital · 12d
Cleared Aug 02, 2004
OLYMPUS STERILIZATION TRAYS
K033222 · KCT
Olympus Winter & Ibe GmbH
General Hospital · 304d
Cleared Jul 28, 2004
PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
K041410 · FPA
Icu Medical, Inc.
General Hospital · 62d