FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,754 results
9049–9072 of 17,754
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 08, 1997
CLEARVIEW BLOWER/MISTER
K973485 · FQH
Dlp, Inc.
General Hospital · 84d
Cleared Dec 08, 1997
DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)
K973510 · FMF
Immuno-U.S., Inc.
General Hospital · 83d
Cleared Dec 04, 1997
VAPOPHENE
K961289 · MED
Germiphene Corp.
General Hospital · 609d
Cleared Dec 04, 1997
POWDER-FREE EXAM GLOVES
K970773 · LYY
Pt. Sarana Indoprotex
General Hospital · 275d
Cleared Dec 04, 1997
PERSONAL INFUSOR
K971362 · MEB
Science Incorporated
General Hospital · 237d
Cleared Dec 04, 1997
GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
K971920 · FYA
Customed, Inc.
General Hospital · 195d
Cleared Dec 04, 1997
MENTOR SUPER ABSORBENT DRAPE
K973146 · KKX
Mentor Ophthalmics, Inc.
General Hospital · 104d
Cleared Dec 04, 1997
UNIFINE PENTIPS
K973899 · FMI
Owen Mumford USA, Inc.
General Hospital · 51d
Cleared Dec 02, 1997
ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
K965016 · CAH
Gibeck, Inc.
General Hospital · 351d
Cleared Dec 01, 1997
MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
K972064 · FRA
Biological Controls, Inc.
General Hospital · 181d
Cleared Nov 24, 1997
PERIPHERALLY INSERTED CENTRAL
K971999 · LJS
B.Braun Medical, Inc.
General Hospital · 178d
Cleared Nov 24, 1997
CHARTERMED TPN-EVA BAGS
K973103 · KPE
Chartermed, Inc.
General Hospital · 97d
Cleared Nov 24, 1997
J-TIP INJECTOR
K973254 · KZE
National Medical Products, Inc.
General Hospital · 87d
Cleared Nov 24, 1997
VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
K973558 · FEB
Ultracell Medical Technologies, Inc.
General Hospital · 66d
Cleared Nov 21, 1997
SPIROSAFE FILTER
K973314 · CAH
Micro Direct, Inc.
General Hospital · 79d
Cleared Nov 21, 1997
HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)
K973801 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 46d
Cleared Nov 21, 1997
HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR)
K973815 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 45d
Cleared Nov 20, 1997
FLUID CENTURION (4-100-00)
K973025 · FLN
Northgate Technologies, Inc.
General Hospital · 98d
Cleared Nov 20, 1997
DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
K973162 · IWE
Hogan & Hartson
General Hospital · 90d
Cleared Nov 18, 1997
Hi Coat Powder Free Latex Patient Examination Gloves
K972539 · LYY
P.T. Latexindo Tobaperkasa
General Hospital · 133d
Cleared Nov 18, 1997
SIMPULSE
K972549 · FNM
Kinetic Concepts, Inc.
General Hospital · 133d
Cleared Nov 18, 1997
VINYL PATIENT EXAMINATION GLOVES POWDERED
K973902 · LYZ
Everrise Glove Products Co., Ltd.
General Hospital · 35d
Cleared Nov 18, 1997
VINYL PATIENT EXAMINATION GLOVES POWDER-FREE
K973998 · LYZ
Everrise Glove Products Co., Ltd.
General Hospital · 28d
Cleared Nov 17, 1997
VITAL-PORT INFUSION PAL
K971140 · LJT
Med Institute, Inc.
General Hospital · 234d