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
8713–8736 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 06, 1998
IRRIGATION SYRINGE KIT
K982435 · KYZ
Sub-Q, Inc.
General Hospital · 116d
Cleared Nov 06, 1998
VINYL EXAMINATION GLOVES, POWDER FREE
K982933 · LYZ
General Gloves Corp.
General Hospital · 78d
Cleared Nov 06, 1998
QLICKSMART
K983367 · MMK
Handren Assoc.
General Hospital · 43d
Cleared Nov 06, 1998
LOW PH PHENOLIC 256
K983585 · LRJ
Central Solutions, Inc.
General Hospital · 24d
Cleared Nov 05, 1998
POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES
K981064 · LZA
P.T. Irama Dinamika Latex
General Hospital · 227d
Cleared Nov 05, 1998
H-RAY
K982720 · LYZ
Shijiazhuang Hongray Plastic Products...
General Hospital · 93d
Cleared Nov 05, 1998
VINYL EXAM GLOVES, POWDER FREE
K983494 · LYZ
Glormed Intl., Inc.
General Hospital · 31d
Cleared Nov 05, 1998
EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM...
K983608 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 22d
Cleared Nov 05, 1998
POWDER-FREE NON STERILE VINYL EXAMINATION GLOVES
K983612 · LYZ
Shanghai Jiatai Plastic Products Co.,...
General Hospital · 22d
Cleared Nov 04, 1998
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
K982838 · FRN
Sims Deltec, Inc.
General Hospital · 84d
Cleared Nov 03, 1998
ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152,...
K983294 · KPE
Baxter Healthcare Corp
General Hospital · 43d
Cleared Nov 02, 1998
LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED
K981600 · LYY
Young Innovations, LLC Dba Plak Smacker
General Hospital · 182d
Cleared Nov 02, 1998
UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)
K982611 · LYY
Uniject Gloves Pcl
General Hospital · 129d
Cleared Nov 02, 1998
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
K982836 · FRN
Sims Deltec, Inc.
General Hospital · 82d
Cleared Nov 02, 1998
CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
K982839 · MEA
Sims Deltec, Inc.
General Hospital · 82d
Cleared Nov 02, 1998
CITREX HOSPITAL SPRAY DISINFECTANT
K982985 · LRJ
Caltech Industries, Inc.
General Hospital · 68d
Cleared Nov 02, 1998
BARCHENS COMPANY DIGITAL PACIFIER THERMOMETER
K983619 · FLL
Barchens Co.
General Hospital · 18d
Cleared Oct 30, 1998
FINE-JECT
K983067 · FMI
Henke Sass Wolf of America, Inc.
General Hospital · 58d
Cleared Oct 30, 1998
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K983207 · LYZ
Shijiazhuang Great Eagle Plastic...
General Hospital · 46d
Cleared Oct 29, 1998
SEMPERMED SURGEONS' GLOVES - SUPREME
K981096 · KGO
Semperit Technische Produkte Gesellshaft
General Hospital · 218d
Cleared Oct 29, 1998
STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS
K981497 · FRC
Steritec Products Mfg Co, Inc.
General Hospital · 185d
Cleared Oct 29, 1998
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K982131 · LZA
Ansell Edmont Industrial, Inc.
General Hospital · 134d
Cleared Oct 28, 1998
VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608
K982541 · FMI
Becton Dickinson Vacutainer Systems
General Hospital · 99d
Cleared Oct 28, 1998
MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS
K982693 · FYA
Medline Industries, Inc.
General Hospital · 86d