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"
3265–3288 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 11, 2000
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · MEA
Baxter Healthcare Corp
General Hospital · 10d
Cleared Sep 05, 2000
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
K002380 · FRN
Baxter Healthcare Corp
General Hospital · 32d
Cleared Sep 01, 2000
EQUIPMENT DRAPES
K002508 · KKX
Allegiance Healthcare Corp.
General Hospital · 17d
Cleared Aug 25, 2000
KARMAN WHEELCHAIR
K002202 · IOR
Karman Healthcare, Inc.
Physical Medicine · 36d
Cleared Aug 25, 2000
KARMAN WHEELCHAIR
K002167 · IOR
Karman Healthcare, Inc.
Physical Medicine · 38d
Cleared Aug 16, 2000
SURGICAL DYNAMICS SPINAL RETRACTOR
K002008 · HRX
United States Surgical, A Division of...
Orthopedic · 44d
Cleared Aug 15, 2000
SURGICAL DRAPES
K002419 · KKX
Allegiance Healthcare Coporation
General Hospital · 7d
Cleared Aug 11, 2000
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K993875 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 270d
Cleared Aug 04, 2000
ALLEGIANCE GENESIS CONTAINER SYSTEM
K983299 · FRG
Allegiance Healthcare Corp.
General Hospital · 683d
Cleared Aug 04, 2000
ENRAF-NONIUS SONOPULS 190 SYSTEM
K000084 · IMI
Henley Healthcare, Inc.
Physical Medicine · 205d
Cleared Jul 31, 2000
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
K001883 · HIS
Ansell Healthcare, Inc.
Obstetrics & Gynecology · 40d
Cleared Jul 28, 2000
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP...
K002211 · FRN
Baxter Healthcare Corp
General Hospital · 7d
Cleared Jul 27, 2000
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS...
K001739 · LYY
Allegiance Healthcare Corp.
General Hospital · 49d
Cleared Jul 18, 2000
AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
K001450 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 71d
Cleared Jul 14, 2000
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT...
K001924 · KGO
Allegiance Healthcare Corp.
General Hospital · 21d
Cleared Jul 11, 2000
KLINIDRAPE REINFORCED SURGICAL GOWNS
K000902 · FYA
Molnlycke Health Care, Inc.
General Hospital · 112d
Cleared Jul 07, 2000
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7,...
K001063 · DYG
Baxter Healthcare Corp
Cardiovascular · 95d
Cleared Jul 05, 2000
TISSOMAT AND SPRAY SET
K981089 · FMF
Baxter Healthcare Corp
General Hospital · 833d
Cleared Jul 05, 2000
KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD...
K000901 · FYA
Molnlycke Health Care, Inc.
General Hospital · 106d
Cleared Jul 03, 2000
OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907
K001848 · DXN
Omron Healthcare, Inc.
Cardiovascular · 14d
Cleared Jun 30, 2000
ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
K001671 · DXN
Omron Healthcare, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2000
AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
K001670 · DXN
Omron Healthcare, Inc.
Cardiovascular · 29d
Cleared Jun 30, 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE...
K000952 · LYY
Pamitex Industries Sdn Bhd
General Hospital · 98d
Cleared Jun 23, 2000
RESOLVE SURGICAL O.R. TOWELS
K001667 · KKX
Allegiance Healthcare Corp.
General Hospital · 23d