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
6121–6144 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 16, 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES WHITE (NON-COLORED)
K051923 · LYZ
Shijiazhuang Wonder Plastic Co., Ltd.
General Hospital · 32d
Cleared Aug 16, 2005
BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
K050971 · LZG
Biovalve Technologies, Inc.
General Hospital · 120d
Cleared Aug 15, 2005
C CHANGE SOLUTION WARMER
K051819 · LHC
C Change Surgical, LLC
General Hospital · 41d
Cleared Aug 15, 2005
3L SURGICAL DRAPES
K043015 · KKX
3l Medical Products Co., Ltd.
General Hospital · 286d
Cleared Aug 12, 2005
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
K051777 · LZA
Hartalega Sdn Bhd
General Hospital · 42d
Cleared Aug 12, 2005
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121,...
K051370 · JOL
Baxter Healthcare Corp
General Hospital · 78d
Cleared Aug 12, 2005
BIOGEL LATEX STERILE POWDER-FREE GLOVE
K050899 · KGO
Regent Medical Americas, LLC
General Hospital · 123d
Cleared Aug 04, 2005
DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM
K051660 · KMH
Coltene/Whaledent, Inc.
General Hospital · 43d
Cleared Aug 03, 2005
POWDER-FREE VINYL EXAM GLOVES
K052006 · LYZ
Baoding Guanzhong Glove Co., Ltd.
General Hospital · 9d
Cleared Aug 03, 2005
CML 1000
K051437 · FPA
Icu Medical, Inc.
General Hospital · 63d
Cleared Aug 03, 2005
POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY...
K051378 · LZA
Medline
General Hospital · 69d
Cleared Aug 02, 2005
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K051935 · LYZ
Shijiazhuang Wonder Plastic Co., Ltd.
General Hospital · 18d
Cleared Aug 02, 2005
CARLO SURGICAL GOWN
K051426 · FYA
Sofilm Technology Co., Ltd.
General Hospital · 62d
Cleared Aug 02, 2005
SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30
K051045 · FRN
Spectrx, Inc.
General Hospital · 99d
Cleared Aug 01, 2005
MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
K051939 · FPA
Medegen Medical Manufacturing System
General Hospital · 14d
Cleared Aug 01, 2005
POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING
K051683 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 39d
Cleared Aug 01, 2005
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · CAH
Fisher &Paykel Healthcare , Ltd.
General Hospital · 110d
Cleared Jul 27, 2005
DISPOSABLE POWDER FREE VINYL EXAM GLOVE YELLOW COLOR
K051393 · LYZ
Ever Global Enterprise Corporation
General Hospital · 61d
Cleared Jul 27, 2005
CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110...
K050463 · FLL
Taidoc Technology Corporation
General Hospital · 154d
Cleared Jul 26, 2005
NITRILE POWDERED EXAMINATION GLOVES (BLUE)
K051778 · LZA
Hartalega Sdn Bhd
General Hospital · 25d
Cleared Jul 26, 2005
MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER
K050542 · LJS
Marian Medical, Inc.
General Hospital · 146d
Cleared Jul 25, 2005
SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE
K051720 · FMF
Synthes (Usa)
General Hospital · 28d
Cleared Jul 25, 2005
BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667,...
K051194 · LJS
Becton, Dickinson & CO
General Hospital · 76d
Cleared Jul 25, 2005
MILTEX RIGID STERILIZATION CONTAINER SYSTEM
K050570 · KCT
Miltex, Inc.
General Hospital · 143d