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
8953–8976 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 13, 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
K980572 · LYY
Hartalega Sdn Bhd
General Hospital · 24d
Cleared Mar 13, 1998
LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES
K980618 · LYY
Lovytex Sdn Bhd
General Hospital · 23d
Cleared Mar 12, 1998
BREATHING CIRCUIT BACTERIAL FILTER
K973797 · CAH
King Systems Corp.
General Hospital · 157d
Cleared Mar 11, 1998
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC...
K973238 · CAH
Bill Olson Corp.
General Hospital · 195d
Cleared Mar 11, 1998
72 HOUR USE TRACH CARE WITH MICROBAN
K974630 · CAH
Ballard Medical Products
General Hospital · 89d
Cleared Mar 11, 1998
6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE...
K980127 · FPA
Catheter Innovations, Inc.
General Hospital · 56d
Cleared Mar 11, 1998
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
K980318 · LYY
Hartalega Sdn Bhd
General Hospital · 43d
Cleared Mar 10, 1998
TEMPO AND TEMP H20
K973748 · LGZ
Smith
General Hospital · 160d
Cleared Mar 10, 1998
HEAT STACK
K980086 · LGZ
Medical Solutions, Inc.
General Hospital · 60d
Cleared Mar 09, 1998
NP MEDICAL CAPLESS LUER ACTIVATED VALVE
K973916 · FPA
Np Medical, Inc.
General Hospital · 146d
Cleared Mar 09, 1998
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE
K974758 · JOL
Hydrox Laboratories
General Hospital · 80d
Cleared Mar 09, 1998
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
K974759 · JOL
Hydrox Laboratories
General Hospital · 80d
Cleared Mar 09, 1998
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
K980092 · FRN
Smith & Nephew, Inc.
General Hospital · 59d
Cleared Mar 04, 1998
J-TIP NEEDLESS INJECTOR
K980082 · KZE
National Medical Products, Inc.
General Hospital · 54d
Cleared Mar 03, 1998
PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE
K962903 · FLE
Prestige Medical Corp.
General Hospital · 586d
Cleared Mar 03, 1998
PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL...
K980381 · LHI
Carmel Pharma Ab.
General Hospital · 29d
Cleared Mar 02, 1998
THERAPORT LOW-PROFILE VASCULAR ACCESS SYSTEM MODELS 1011 AND 1012
K974475 · LJT
Biocontrol Technology, Inc.
General Hospital · 96d
Cleared Mar 02, 1998
DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE
K980093 · LYZ
Universal Gloves Corp.
General Hospital · 52d
Cleared Feb 26, 1998
ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD
K972877 · FMF
Safety Syringes, Inc.
General Hospital · 206d
Cleared Feb 26, 1998
ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW)
K972883 · FXX
Cypress Medical Products, Ltd.
General Hospital · 205d
Cleared Feb 26, 1998
ULTRASAFE MODEL T200 INJECTOR
K972900 · FMF
Safety Syringes, Inc.
General Hospital · 204d
Cleared Feb 26, 1998
INTROSYTE CATHETER
K974764 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 69d
Cleared Feb 26, 1998
PROMAX SURGICAL DRAPES AND COVERS
K980183 · KKX
Standard Textile Co., Inc.
General Hospital · 37d
Cleared Feb 25, 1998
NITRILE EXAM GLOVE, POWDER-FREE/WHITE AND BLUE
K974710 · LZA
Sinochem Ningbo Latex Gloves Factory
General Hospital · 70d