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"
4969–4992 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 14, 1982
ADHESIVE REMOVER
K821162 · KOX
The Healthcare Group Laboratories, Inc.
General & Plastic Surgery · 18d
Cleared May 10, 1982
EXTERNAL URINARY MALE INCONTINENCE DEV
K821161 · KNX
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared May 10, 1982
URINARY COLLECTION CONTAINER/LEG BAG
K821171 · KNX
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared May 10, 1982
EXTERNAL FEMALE URINARY INCONTINENCE
K821172 · KNX
The Healthcare Group Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 15, 1982
INFANT MONITOR
K820645 · BZQ
Healthdyne, Inc.
Anesthesiology · 37d
Cleared Apr 09, 1982
PEDIATRIC SUCKER
K820638 · KDC
3M Health Care, Sarns
General & Plastic Surgery · 32d
Cleared Mar 26, 1982
PFLEX TM
K820528 · BWF
Health Scan, Inc.
Anesthesiology · 25d
Cleared Mar 15, 1982
POWERED TREADMILL
K820548 · IOL
Ogden Health Products
Physical Medicine · 13d
Cleared Feb 10, 1982
VIT-O-METER
K820032 · BZG
Health Scan, Inc.
Anesthesiology · 35d
Cleared Feb 05, 1982
STERI-SHURE
K820147 · JOJ
General Health Systems, Inc.
General Hospital · 17d
Cleared Feb 04, 1982
JET VENTILATOR
K813254 · CBK
Healthdyne, Inc.
Anesthesiology · 77d
Cleared Jan 28, 1982
MODEL AS6B INFUSION PUMP
K813590 · FRN
Baxter Healthcare Corp
General Hospital · 31d
Cleared Jan 22, 1982
5B SLAVE MODULE SYRINGE PUMP
K813473 · FRN
Baxter Healthcare Corp
General Hospital · 39d
Cleared Jan 18, 1982
STERILE ORTHOPEDIC STOCKINETTE
K812904 · LGF
Alba Health Care
Orthopedic · 91d
Cleared Dec 02, 1981
AUTO-SYRINGE SUB-CUTEANEOUS SET
K813194 · FPA
Baxter Healthcare Corp
General Hospital · 15d
Cleared Nov 24, 1981
SILASTIC VOICE PROSTHESIS
K812864 · EWL
Dow Corning Corp. Healthcare...
Ear, Nose, Throat · 42d
Cleared Nov 06, 1981
HEALTH-UP
K812432 · GZJ
Wfx Industries, Inc.
Neurology · 73d
Cleared Oct 26, 1981
OXEQUIP CONDUCTIVE & NON ANES. BREATH
K812624 · CAI
Oxequip Health Ind.
Anesthesiology · 41d
Cleared Oct 23, 1981
SPIROMETER FILTER
K812573 · CAH
K & G Healthcare Ind., Inc.
General Hospital · 44d
Cleared Sep 23, 1981
GER 540, GER 541 MANUAL BED
K812600 · FNJ
G.W. Healthcare, Inc.
General Hospital · 9d
Cleared Aug 20, 1981
VACUUM SUCTION FILTER
K812139 · KDQ
K & G Healthcare Ind., Inc.
General Hospital · 23d
Cleared Aug 18, 1981
SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
K812053 · KXE
Dow Corning Corp. Healthcare...
Orthopedic · 28d
Cleared Aug 18, 1981
MINI NICHOLES
K812098 · CAH
Healthcare Ind.
General Hospital · 25d
Cleared Aug 12, 1981
NICHOLE'S 99
K812075 · CAH
Healthcare Ind.
General Hospital · 21d