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"
4873–4896 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 01, 1985
DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET
K850255
Dow Corning Corp. Healthcare...
Orthopedic · 99d
Cleared Apr 23, 1985
TF-II HIP PROSTHESIS
K843995 · KWL
Dow Corning Corp. Healthcare...
Orthopedic · 194d
Cleared Apr 17, 1985
ALBA DRY BURN PAD
K850881
Alba Health Care
General & Plastic Surgery · 44d
Cleared Apr 17, 1985
ALBA DRY BURN DRESSING
K850904 · NAD
Alba Health Care
General & Plastic Surgery · 43d
Cleared Apr 12, 1985
HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2
K851379 · FLL
Healthcheck Corp.
General Hospital · 4d
Cleared Mar 20, 1985
VISOPROTECT OCCULAR SHIELD
K850005 · HMP
M.S.G. Health Systems, Inc.
General & Plastic Surgery · 77d
Cleared Mar 12, 1985
ALBA HEALTH CARE NON-ADHERING DRESSING
K850241 · FRO
Alba Health Care
General & Plastic Surgery · 49d
Cleared Mar 11, 1985
TRACHEOSTOMY CARE KIT
K850456 · BTO
Excel Health Care Products
Anesthesiology · 33d
Cleared Feb 26, 1985
STERILE SUTURE REMOVAL KIT
K850325 · KDD
Excel Health Care Products
General & Plastic Surgery · 29d
Cleared Feb 26, 1985
STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH
K850326 · KKX
Excel Health Care Products
General Hospital · 29d
Cleared Feb 21, 1985
POLY-LINED TOWEL/DRAPE LINE
K850199 · KKX
Excel Health Care Products
General Hospital · 34d
Cleared Feb 07, 1985
FLUOROSCAN/TM BY HEALTHMATE
K843920 · JAA
Healthmate, Inc.
Radiology · 125d
Cleared Jan 22, 1985
HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2
K850070 · DXN
Healthcheck Corp.
Cardiovascular · 18d
Cleared Jan 04, 1985
LATEX-R RICKETTSII
K843794 · GPP
Health Research, Inc.
Microbiology · 99d
Cleared Dec 20, 1984
WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
K842559 · KWL
Dow Corning Corp. Healthcare...
Orthopedic · 171d
Cleared Dec 10, 1984
PTK HEALTHCHECK PREGNANCY TEST KIT
K844281 · LCX
Healthcheck Corp.
Chemistry · 35d
Cleared Nov 29, 1984
HEALTH PULSE FA-222 TRANSCUTANEOUS ELEC. NERVE STI
K843637 · GZJ
Therapeutic Equipment Corp.
Neurology · 73d
Cleared Nov 23, 1984
HEALTH PULSE FA-222 POWER MUSCLE STIMUL
K843638 · IPF
Therapeutic Equipment Corp.
Physical Medicine · 67d
Cleared Nov 05, 1984
HTS FILTER DIGITAL SUBTRACT. ANGIOGRAPHY
K842691
Health Technology Services
Neurology · 117d
Cleared Oct 31, 1984
AUTO SUTURE POLY GIA SURGICAL STAPLER
K843603 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 72d
Cleared Oct 19, 1984
EMPTY SOLUTION TRANSFER CONTAINER
K842170 · KPE
The Healthcare Group Laboratories, Inc.
General Hospital · 148d
Cleared Oct 10, 1984
INFANT MONITOR 16900
K843546 · BZQ
Healthdyne, Inc.
Anesthesiology · 30d
Cleared Sep 25, 1984
AUTO SUTURE SURGICLIP DISPOS. CLIP APPL
K843312
United States Surgical, A Division of...
General & Plastic Surgery · 32d
Cleared Aug 24, 1984
QUALINE WHEELCHAIR PRODUCTS
K843213 · IQC
Contemporary Health Sys
Physical Medicine · 9d