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"
4801–4824 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 12, 1987
PROCON
K864218 · KNT
Healthcare Management Systems
Gastroenterology & Urology · 76d
Cleared Dec 29, 1986
U66 EMS
K864558 · IPF
Suntec Health & Fitness Group, Inc.
Physical Medicine · 59d
Cleared Dec 24, 1986
HEALTH PRODUCTS, INC. ORTHODERM THERAPY CHAIR
K864918 · INO
Health Products, Inc.
Physical Medicine · 8d
Cleared Dec 22, 1986
HEALTHPHONE(TM)
K862668 · DXH
Carelink
Cardiovascular · 161d
Cleared Dec 11, 1986
MODIFIED SARNS MEMBRANE OXYGENATOR
K863902 · DTX
3M Health Care, Sarns
Cardiovascular · 65d
Cleared Nov 18, 1986
MODIFIED SARNS OXYGENATOR SYSTEM
K863515 · DTZ
3M Health Care, Sarns
Cardiovascular · 69d
Cleared Nov 18, 1986
SARNS SAFETY LOOP
K863593 · DWD
3M Health Care, Sarns
Cardiovascular · 64d
Cleared Nov 06, 1986
NATURAL DETECTOR SYSTEM
K861731 · KHE
U.S. Health Resources Corp.
Hematology · 184d
Cleared Oct 16, 1986
HYDRO-CLENZ UNIT
K863539 · KPL
Atlantic Health Group
Gastroenterology & Urology · 35d
Cleared Oct 16, 1986
SODIUM BICARBONATE POWDER/BICARBONATE HEMODIALYSIS
K863631 · KPO
American Healthcare Corp.
Gastroenterology & Urology · 29d
Cleared Oct 02, 1986
DISPOSABLE PNEUMOPERITONEUM NEEDLE
K863330 · FHO
United States Surgical, A Division of...
Gastroenterology & Urology · 44d
Cleared Sep 11, 1986
HEALTHCHECK THERM-STRIP
K863181 · FQZ
Healthcheck Corp.
General Hospital · 23d
Cleared Aug 25, 1986
PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER
K860289 · GWL
Professional Health Technologies, Inc.
Neurology · 209d
Cleared Aug 19, 1986
MODIFIED CARDIOTOMY RESERVOIR 5M1470
K862357 · DTN
3M Health Care, Sarns
Cardiovascular · 57d
Cleared Jul 23, 1986
STERILE DISPOSABLE TROCAR-SLEEVE DEVICES
K862611 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 15d
Cleared Jul 17, 1986
DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET
K861390 · FMI
Baxter Healthcare Corp
General Hospital · 94d
Cleared Jul 11, 1986
DIGITAL ELECTRONIC MYO-GRAPH (MUSCLE ANALYZER)
K862128 · KQX
Health Products, Inc.
Neurology · 37d
Cleared Jul 09, 1986
ULTRATAN TANNING SYSTEM
K862372 · FTC
Health Systems Intl., Inc.
General & Plastic Surgery · 15d
Cleared Jul 08, 1986
ADCOMP
K860610 · LHI
Healthtek, Inc.
General Hospital · 139d
Cleared Jun 30, 1986
META - HEALTH MODEL MTG III
K861771 · FLL
Meta Health, Inc.
General Hospital · 54d
Cleared Jun 23, 1986
SARNS PORTABLE POWER MODULE
K861388 · DTQ
3M Health Care, Sarns
Cardiovascular · 70d
Cleared Jun 16, 1986
PTK PLUS. HOME PREGNANCY TEST
K861946 · LCX
Healthcheck Corp.
Chemistry · 27d
Cleared Jun 10, 1986
SURGI-TIE LOOPS
K861161
Healthmed Corp.
General & Plastic Surgery · 74d
Cleared May 30, 1986
FAST FLOW XX (AQUEOUS SOLUTION FILTER)
K860372 · FPB
Healthtek, Inc.
General Hospital · 116d