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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
3697–3720 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 26, 1995
KENDALL SHERIDAN CPAP SYSTEM
K953511 · BYE
Kendall Healthcare Products Co....
Anesthesiology · 92d
Cleared Oct 18, 1995
POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE
K953869 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 82d
Cleared Oct 17, 1995
MODIFIED VERSAPORT
K954108 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 75d
Cleared Oct 03, 1995
KENSORB
K953830 · GDY
Kentron Health Care, Inc.
General & Plastic Surgery · 48d
Cleared Oct 03, 1995
NONPOWERED NEUROSURGICAL INSTRUMENT
K953173 · GWG
United States Surgical, A Division of...
Neurology · 88d
Cleared Oct 03, 1995
AUTO SUTURE* MODIFIED LINEAR STAPLER**
K952239 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 144d
Cleared Sep 27, 1995
HEMA-BENZ
K953405 · KLE
Health-Dent Intl., Inc.
Dental · 69d
Cleared Sep 22, 1995
MEDI-PLUS, HEALTH PLUS, SANITEX, RELIANCE
K953138 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 78d
Cleared Sep 22, 1995
ILIAC CREST BONE MARROW ASPIRATION NEEDLE
K953082 · GDM
Baxter Healthcare Corp
General & Plastic Surgery · 81d
Cleared Sep 21, 1995
PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)
K950331 · BZD
Healthdyne, Inc.
Anesthesiology · 237d
Cleared Sep 13, 1995
KODAK XLS 8600 (PS)
K951948 · LMC
Kodak Health Imaging Systems, Inc.
Radiology · 140d
Cleared Sep 13, 1995
KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER
K951807 · LMC
Kodak Health Imaging Systems, Inc.
Radiology · 147d
Cleared Sep 08, 1995
TMR48
K953342 · INO
Pride Health Care, Inc.
Physical Medicine · 59d
Cleared Sep 06, 1995
3 LPM OXYGEN CONCENTRATOR
K952037 · CAW
Devilbiss Health Care, Inc.
Anesthesiology · 128d
Cleared Aug 30, 1995
HEALTH IMAGE INC. HI STAR
K944724 · LNH
Health Images, Inc.
Radiology · 339d
Cleared Aug 28, 1995
DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)
K953206 · CAF
Dhd Diemolding Healthcare Div.
Anesthesiology · 90d
Cleared Aug 25, 1995
TAMPON, UNTREATED
K950194 · HEB
Hygieia Healthcare , Ltd.
Obstetrics & Gynecology · 219d
Cleared Aug 24, 1995
DEVILBISS MODEL 5500
K946095 · CAF
Devilbiss Health Care, Inc.
Anesthesiology · 253d
Cleared Aug 23, 1995
INFANT HEEL WARMER
K950680 · IMD
Baxter Healthcare Corp
Physical Medicine · 190d
Cleared Aug 21, 1995
USSC POLYSORB SUTURE
K951520 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 140d
Cleared Aug 21, 1995
USSC MONOFILAMENT POLYSORB SUTURE
K945285 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 294d
Cleared Aug 18, 1995
JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL
K951735 · FNL
Joerns Healthcare, Inc.
General Hospital · 126d
Cleared Aug 18, 1995
FOGARTY-HYDRAGRIP SURGICAL CLAMPS
K951413 · DXC
Baxter Healthcare Corp
Cardiovascular · 143d
Cleared Aug 11, 1995
CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA.
K951949 · BSP
Baxter Healthcare Corp
Anesthesiology · 107d