FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,281 results for "health"
3553–3576 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 29, 1998
GOLEMB DISPOSABLE BAG MASK RESUSCITATOR
K973106 · BTM
Allied Healthcare Products, Inc.
Anesthesiology · 163d
Cleared Jan 28, 1998
PARACENTESIS CATHETER DEVICE
K974146 · GCB
Allegiance Healthcare Corp.
General & Plastic Surgery · 86d
Cleared Jan 26, 1998
HUNTLEIGH FP5000 SYSTEM MODEL FP5000
K965153 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 399d
Cleared Jan 22, 1998
BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS...
K974155 · DTN
Baxter Healthcare Corp
Cardiovascular · 79d
Cleared Jan 22, 1998
ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA
K974122 · MQX
Scientific Health Care
General Hospital · 83d
Cleared Jan 20, 1998
TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI...
K972614 · CAW
Healthdyne Technologies, Inc.
Anesthesiology · 190d
Cleared Jan 11, 1998
CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G)
K970663 · MSF
Baxter Healthcare Corp
Gastroenterology & Urology · 324d
Cleared Jan 06, 1998
POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM)
K974065 · LYY
Tillotson Healthcare Corp.
General Hospital · 71d
Cleared Dec 31, 1997
KENDALL CURITY IODOFORM PACKING STRIP
K973763 · EFQ
Kendall Healthcare Products Co....
General & Plastic Surgery · 90d
Cleared Dec 18, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K973913 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 65d
Cleared Dec 17, 1997
DENT-TEMP ACRYLIC
K972198 · EBG
Health-Dent Intl., Inc.
Dental · 189d
Cleared Dec 16, 1997
BENEFIT B3--- SERIES
K974254 · FNL
M.C. Healthcare Products, Inc.
General Hospital · 33d
Cleared Dec 16, 1997
KENDALL CURITY PETROLATUM GAUZE
K973511 · FRO
Kendall Healthcare Products Co....
General & Plastic Surgery · 90d
Cleared Dec 15, 1997
KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
K973507 · FRO
Kendall Healthcare Products Co....
General & Plastic Surgery · 90d
Cleared Dec 10, 1997
KENDALL CURITY NON-ADHERING DRESSING
K973619 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 78d
Cleared Dec 08, 1997
3M CDI H/S CUVETTES WITH HEPARON TREATMENT
K973472 · DRY
3M Healthcare
Cardiovascular · 87d
Cleared Dec 04, 1997
JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
K973703 · GBX
Allegiance Healthcare Corp.
General & Plastic Surgery · 69d
Cleared Dec 04, 1997
KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
K973509 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 79d
Cleared Dec 01, 1997
THE AUTO SUTURE* MIBB** SYSTEM
K973496 · KNW
United States Surgical, A Division of...
Gastroenterology & Urology · 77d
Cleared Nov 26, 1997
ENDOASSIST
K973249 · GCJ
Armstrong Healthcare , Ltd.
General & Plastic Surgery · 89d
Cleared Nov 24, 1997
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
K963933 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 419d
Cleared Nov 19, 1997
SKAR-KARE
K973271 · MDA
Target Health, Inc.
General & Plastic Surgery · 78d
Cleared Nov 18, 1997
INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
K970107 · EOQ
Urohealth Systems, Inc.
Ear, Nose, Throat · 309d
Cleared Nov 13, 1997
ALLEGIANCE KWIK HEAT WARM PERINEAL PACK
K973770 · IMD
Allegiance Healthcare Corp.
Physical Medicine · 42d