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
3553–3576 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 19, 2014
AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
K141640 · MEG
Shantou Wealy Medical Instrument Co.,Ltd
General Hospital · 153d
Cleared Nov 17, 2014
SURGICAL GOWN
K141606 · FYA
Cobes Industries Co., Ltd.
General Hospital · 154d
Cleared Nov 14, 2014
HEPARIN LOCK / FLUSH SYRINGES
K133446 · NZW
Excelsior Medical Corporation
General Hospital · 367d
Cleared Nov 13, 2014
OMNIPOD INSULIN MANAGEMENT SYSTEM
K140439 · LZG
Insulet Corporation
General Hospital · 265d
Cleared Nov 10, 2014
LEAF PATIENT MONITORING SYSTEM
K141877 · KMI
Leaf Healthcare, Inc.
General Hospital · 122d
Cleared Nov 10, 2014
KIMGUARD SMART-FOLD STERILIZATION WRAP
K140963 · FRG
Kimberly-Clark Corp.
General Hospital · 209d
Cleared Nov 06, 2014
SENSIFLEX PLUS STERILE LATEX SURGICAL GLOVE POWDERFREE WITH PROTEIN CONTENT...
K140355 · KGO
Terang Nusa Sdn Bhd
General Hospital · 267d
Cleared Nov 06, 2014
YONGFA
K140246 · LYZ
Yongfa Glove Co., Ltd.
General Hospital · 280d
Cleared Nov 06, 2014
YONGHE
K140244 · LYZ
Yonghe Plastic Products Co., Ltd.
General Hospital · 280d
Cleared Nov 03, 2014
STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR
K141238 · FRC
Sterilucent, Inc.
General Hospital · 174d
Cleared Oct 31, 2014
T:SLIM INSULIN DELIVERY SYSTEM
K141758 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 123d
Cleared Oct 31, 2014
STERILUCENT PROCESS CHALLENGE DEVICE
K141312 · FRC
Sterilucent, Inc.
General Hospital · 164d
Cleared Oct 31, 2014
STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER
K140464 · MLR
Sterilucent, Inc.
General Hospital · 249d
Cleared Oct 27, 2014
PROCESS INDICATOR TAPE FOR STEAM STERILIZATION
K140940 · JOJ
Canadian Technical Tape, Ltd.
General Hospital · 196d
Cleared Oct 24, 2014
OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS
K141759 · MMK
Oak Ridge Products, LLC
General Hospital · 115d
Cleared Oct 17, 2014
Merit 10mL Syringe
K142636 · FMF
Merit Medical Systems, Inc.
General Hospital · 30d
Cleared Oct 17, 2014
Sherlock 3CG Tip Positioning System Stylet
K142267 · LJS
C.R. Bard, Inc.
General Hospital · 63d
Cleared Oct 17, 2014
EMG BLACK NITRILE MEDICAL EXAMINATION GLOVE POWDER FREE
K141579 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 126d
Cleared Oct 17, 2014
HALO AMBULATORY INFUSION SYSTEM
K140783 · FRN
Zyno Medical, LLC
General Hospital · 200d
Cleared Oct 14, 2014
PICC Maximal Barrier Nursing Kit
K142616 · LJS
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Oct 07, 2014
EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE WITH CHEMOTHERAPY DRUG LABELING CLAIM
K141623 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 112d
Cleared Oct 07, 2014
EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
K141510 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 120d
Cleared Oct 02, 2014
SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION
K141664 · MEG
Rexam Healthcare
General Hospital · 101d
Cleared Oct 02, 2014
PADI-LOCK
K141200 · FPA
Padi-Lock, LLC
General Hospital · 146d