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
9193–9216 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 04, 1997
BKMI DISPOSABLE SYRINGE
K971487 · FMI
Sumi Salud C.A.
General Hospital · 134d
Cleared Sep 03, 1997
FACE MASK, SURGICAL MASK, NON-STERILE
K970835 · FXX
Tucker & Associates
General Hospital · 196d
Cleared Sep 02, 1997
SMART SET
K972663 · FPA
Top Spins, Inc.
General Hospital · 56d
Cleared Aug 29, 1997
AMBIDERM
K971102 · LYY
Supertex Industrial, S.A. DE C.V.
General Hospital · 156d
Cleared Aug 29, 1997
W.A.
K971200 · LYY
W.A. Rubbermate Co., Ltd.
General Hospital · 150d
Cleared Aug 29, 1997
SPOROX TEST STRIPS
K972035 · JOJ
Serim Research Corp.
General Hospital · 88d
Cleared Aug 29, 1997
VOLKER HOSPITAL BED, MODEL K960
K972115 · FNL
Volker Healthcare, Inc.
General Hospital · 85d
Cleared Aug 29, 1997
SHARPS SHUTTLE
K972279 · FMI
Sage Products, Inc.
General Hospital · 72d
Cleared Aug 27, 1997
NURSES BOUFFANT CAP
K965237 · LYU
Copioumed Intl., Inc.
General Hospital · 239d
Cleared Aug 27, 1997
POLY (VINYL) EXAM GLOVE, POWDERED
K971316 · LYZ
Copioumed Intl., Inc.
General Hospital · 140d
Cleared Aug 27, 1997
SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE
K972469 · FMI
Beech Medical Products, Inc.
General Hospital · 57d
Cleared Aug 26, 1997
BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER
K971763 · FMI
Retractable Technologies, Inc.
General Hospital · 105d
Cleared Aug 26, 1997
MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW
K972117 · LHI
Medical Specialty Innovations, Inc....
General Hospital · 82d
Cleared Aug 26, 1997
BAG DECANTER
K972134 · LHI
Remington Medical, Inc.
General Hospital · 81d
Cleared Aug 26, 1997
MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
K972135 · FPA
P/L Biomedical
General Hospital · 81d
Cleared Aug 25, 1997
NITRILE GLOVES
K970135 · LZC
Sage Products, Inc.
General Hospital · 222d
Cleared Aug 25, 1997
ACCUTEMP-PROBE
K970686 · FMT
Kentec Medical, Inc.
General Hospital · 181d
Cleared Aug 25, 1997
DASH, SULLIVAN, VITAL GARD
K971044 · LYY
Dash Medical Gloves, Inc.
General Hospital · 157d
Cleared Aug 22, 1997
DRAPE, SURGICAL-LATEX
K970891 · KKX
Protek Medical Products, Inc.
General Hospital · 164d
Cleared Aug 22, 1997
WARMETTE
K971117 · LHC
Olympic Medical Corp.
General Hospital · 148d
Cleared Aug 21, 1997
ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
K962577 · FOZ
Arrow Intl., Inc.
General Hospital · 416d
Cleared Aug 21, 1997
RID-DECUBE II
K965207 · FNM
Skin Care Management, Inc.
General Hospital · 237d
Cleared Aug 18, 1997
ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER
K971500 · FPA
Biological & Environmental Control...
General Hospital · 116d
Cleared Aug 15, 1997
POWDER FREE LATEX EXAMINATION GLOVES
K970115 · LYY
Pt Mbf Buana Multicorpora
General Hospital · 214d