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"
4201–4224 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 06, 1992
OMRON COMPRESSOR NEBULIZER- MODEL NE-C09
K914836 · CAF
Omron Healthcare, Inc.
Anesthesiology · 194d
Cleared May 06, 1992
AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR
K914190 · GAD
United States Surgical, A Division of...
General & Plastic Surgery · 231d
Cleared Apr 20, 1992
IDENTI LOOPS DEGANIA SILICONE
K920104 · DSS
Puritas Health Care, Inc.
Cardiovascular · 102d
Cleared Apr 06, 1992
AVI MODEL 285CI INFUSION PUMP
K920681 · FRN
3M Health Care, Ltd.
General Hospital · 52d
Cleared Apr 06, 1992
AVI MODEL 275CI INFUSION PUMP
K920680 · FRN
3M Health Care, Ltd.
General Hospital · 52d
Cleared Apr 06, 1992
AVI MODEL 3000 INFUSION PUMP
K920588 · FRN
3M Health Care, Ltd.
General Hospital · 56d
Cleared Apr 06, 1992
LAP TISSUE COLLECTION BAG
K915286 · GCJ
Baxter Healthcare Corp
General & Plastic Surgery · 133d
Cleared Apr 03, 1992
HEALTH PAK TRAY SOX BARRIERS
K920052 · KKX
Healthpak, Inc.
General Hospital · 88d
Cleared Mar 23, 1992
8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET
K920694 · FPA
Baxter Healthcare Corp
General Hospital · 38d
Cleared Mar 19, 1992
HOMEVUE MONITORING SYS.MODEL TD 2000
K912138 · HGM
Homevue Health Systems, Inc.
Obstetrics & Gynecology · 310d
Cleared Mar 18, 1992
TRANSFER-AID(TM)
K913985 · LHI
Healthtek, Inc.
General Hospital · 195d
Cleared Mar 13, 1992
HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY
K920221 · KTN
Akers Research Corp.
Immunology · 57d
Cleared Mar 13, 1992
HEALTHTEST RHEUMATOID FACTOR ASSAY
K920220 · DHR
Akers Research Corp.
Immunology · 57d
Cleared Mar 13, 1992
LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM
K913472 · ITX
Baxter Healthcare Corp
Radiology · 221d
Cleared Mar 12, 1992
SHOPRIDER - TE889
K920654 · INI
Pride Health Care, Inc.
Physical Medicine · 29d
Cleared Mar 12, 1992
3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES
K915390 · FPA
Baxter Healthcare Corp
General Hospital · 104d
Cleared Mar 06, 1992
FLO-GARD 8000 HALF-SET
K915499 · FRN
Baxter Healthcare Corp
General Hospital · 88d
Cleared Mar 06, 1992
TAMPON, UNTREATED
K912941 · HEB
Hygieia Healthcare , Ltd.
Obstetrics & Gynecology · 249d
Cleared Mar 04, 1992
SARNS RETROGRADE CANNULA
K915193 · DWF
3M Health Care, Sarns
Cardiovascular · 106d
Cleared Feb 28, 1992
FLO-GARD(R) 6301
K915523 · FRN
Baxter Healthcare Corp
General Hospital · 80d
Cleared Feb 28, 1992
FLO-GARD(R) 6201
K915522 · FRN
Baxter Healthcare Corp
General Hospital · 80d
Cleared Feb 11, 1992
CURAD KID SIZE INSTANT COLD PACK
K920252 · IMD
Kendall Healthcare Products Co....
Physical Medicine · 21d
Cleared Feb 07, 1992
DURALIFE(TM)
K913726 · BZA
Dhd Diemolding Healthcare Div.
Anesthesiology · 171d
Cleared Jan 31, 1992
CURITY VENTED DRESSING SYSTEM
K915635 · MGP
Kendall Healthcare Products Co....
General & Plastic Surgery · 45d