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
9385–9408 of 17,754
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 27, 1997
BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED...
K962666 · FYA
Bemiss-Jason Corp., Triad Medical Div.
General Hospital · 233d
Cleared Feb 27, 1997
JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING
K964845 · LYY
Jinhua Latex Products Factory
General Hospital · 86d
Cleared Feb 27, 1997
NINGBO YUJIANG LATEX EXAMINATION GLOVES, POWDER-FREE, WITH PROTEIN LABELING
K964847 · LYY
Ningbo Yujiang Plastic & Rubber Co. ,...
General Hospital · 86d
Cleared Feb 27, 1997
MR EXTENSION SET (001)
K964968 · FPA
University of Michigan
General Hospital · 77d
Cleared Feb 26, 1997
MODELS IDA-2 PLUS AND IPT-1
K961862 · FRN
Bio-Tek Instruments, Inc.
General Hospital · 288d
Cleared Feb 26, 1997
LIFESHIELD BLUNT CANNULA
K963351 · FMI
Abbott Laboratories
General Hospital · 184d
Cleared Feb 26, 1997
SPONGETRAC
K964181 · MRL
Surgitrac Corp.
General Hospital · 131d
Cleared Feb 26, 1997
POLYFIN EXTENSION SET, MODELS 126 AND 128
K965208 · FPK
Medtronic Minimed
General Hospital · 61d
Cleared Feb 25, 1997
MASK SURGICAL
K963568 · FXX
The Innovative Approach, Corp.
General Hospital · 173d
Cleared Feb 25, 1997
EZTEST
K963841 · FRC
Sgm Biotech, Inc.
General Hospital · 153d
Cleared Feb 25, 1997
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142 · KKX
Medline Industries, Inc.
General Hospital · 132d
Cleared Feb 25, 1997
DISPOSABLE APRON
K964364 · LYU
Instrument Makar, Inc.
General Hospital · 116d
Cleared Feb 25, 1997
MEDRAD CONTRAST HOLDER
K964782 · FOX
Medrad, Inc.
General Hospital · 90d
Cleared Feb 25, 1997
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
K964850 · FPA
Baxter Healthcare Corp
General Hospital · 84d
Cleared Feb 25, 1997
OMNI GRIP LATEX EXAMINATION GLOVE, POWDER-FREE
K970297 · LYY
Omni Sales Corp.
General Hospital · 29d
Cleared Feb 21, 1997
TRI-FLOW THREE WAY STOPCOCK
K961982 · FMG
North, Inc.
General Hospital · 277d
Cleared Feb 21, 1997
9000 SERIES FILTER & FILTER/HME
K963053 · CAH
Enternet Medical, Inc.
General Hospital · 199d
Cleared Feb 19, 1997
RMI DUAL FLUID IRRIGATING SYRINGE
K964833 · KYZ
Research Medical, Inc.
General Hospital · 79d
Cleared Feb 14, 1997
BALDUR VINYL POWDERED GLOVES
K963441 · LYZ
Hti Trading Group
General Hospital · 168d
Cleared Feb 14, 1997
VYGON BIONECTOR WITH EXTENSION SET
K963981 · FPA
Vygon Corp.
General Hospital · 134d
Cleared Feb 14, 1997
AMSEAL SURGICAL FACE MASK
K964358 · FXX
American Seal Co.
General Hospital · 105d
Cleared Feb 14, 1997
JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES
K964800 · LYZ
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 77d
Cleared Feb 14, 1997
BEMIS TWO GALLON SHARPS CONTAINER
K965248 · FMI
Bemis Mfg. Co.
General Hospital · 72d
Cleared Feb 14, 1997
ALPHA MICRON 20/40 MICROAGGREGATE FILTER
K970225 · CAK
Alpha Therapeutic Corp.
General Hospital · 28d