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"
4681–4704 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 15, 1988
EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116
K881449 · LXN
Baxter Healthcare Corp
Cardiovascular · 71d
Cleared Jun 15, 1988
MONITRON SYSTEM
K874148 · DRT
American Health Products, Inc.
Cardiovascular · 246d
Cleared Jun 13, 1988
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
K881215 · FOZ
Baxter Healthcare Corp
General Hospital · 83d
Cleared Jun 13, 1988
CONDOM (PROPHYLACTIC)
K880463 · HIS
Health Technologies Intl.
Obstetrics & Gynecology · 131d
Cleared Jun 07, 1988
DRY COMFORT DISPOSABLE UNDERPAD
K881969 · KME
Health Tec, Inc.
General Hospital · 27d
Cleared Jun 02, 1988
INTRO-REDUCER (NASOGASTRIC TUBE)
K875232 · KNT
Health Improvement Assoc.
Gastroenterology & Urology · 163d
Cleared May 27, 1988
PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II
K881258 · JIX
Baxter Healthcare Corp
Toxicology · 65d
Cleared May 26, 1988
STAIR VEYOR
K882091 · ILK
Pride Health Care, Inc.
Physical Medicine · 7d
Cleared May 26, 1988
HIP SAVER
K882090 · INN
Pride Health Care, Inc.
Physical Medicine · 7d
Cleared May 26, 1988
CHECK VALVE
K881052 · FPA
Baxter Healthcare Corp
General Hospital · 76d
Cleared May 26, 1988
BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS
K880102 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 135d
Cleared May 23, 1988
ADFUSE(TM)
K881590 · FRN
Healthtek, Inc.
General Hospital · 40d
Cleared May 18, 1988
EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
K881279 · DTI
Baxter Healthcare Corp
Cardiovascular · 57d
Cleared May 18, 1988
DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1
K881003 · DXN
Healthcheck Corp.
Cardiovascular · 70d
Cleared Apr 28, 1988
PARAMAX IRON REAGENT
K881104 · JIY
Baxter Healthcare Corp
Chemistry · 44d
Cleared Apr 27, 1988
DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH
K881332 · OCZ
Baxter Healthcare Corp
Gastroenterology & Urology · 29d
Cleared Apr 25, 1988
PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT
K881141 · CAI
Baxter Healthcare Corp
Anesthesiology · 39d
Cleared Apr 21, 1988
FOLDING WHEELCHAIR
K881452 · IOR
Health Care Innovations, Inc.
Physical Medicine · 15d
Cleared Apr 21, 1988
CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.
K881138 · JMG
Baxter Healthcare Corp
Immunology · 36d
Cleared Apr 19, 1988
MTI WOLFF SYSTEM, TANNING BED
K881492 · LEJ
Health Systems Intl., Inc.
General & Plastic Surgery · 11d
Cleared Apr 19, 1988
HALF HOUR INFUSOR
K880625 · FRN
Baxter Healthcare Corp
General Hospital · 63d
Cleared Apr 14, 1988
REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600
K880201 · KNT
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 12, 1988
GRAM NEGATIVE MIC/COMBO PANELS
K880430 · JWY
Baxter Healthcare Corp
Microbiology · 71d
Cleared Apr 11, 1988
BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
K880637 · BZO
Baxter Healthcare Corp
Anesthesiology · 55d