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"
4489–4512 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 04, 1990
BIO-STYM 250 (MUSCLE STIMULATOR)
K891987 · IPF
Electronic Health Technologies, Inc.
Physical Medicine · 282d
Cleared Jan 03, 1990
ELT OR ERGONOMIC LIFT TRAINER
K890500 · HCC
Physical Health Devices, Inc.
Neurology · 336d
Cleared Jan 02, 1990
AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
K896692 · CEM
Baxter Healthcare Corp
Chemistry · 35d
Cleared Jan 02, 1990
LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
K896526 · JGS
Baxter Healthcare Corp
Chemistry · 50d
Cleared Dec 29, 1989
MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE
K891986 · KME
Mark One Healthcare Products
General Hospital · 276d
Cleared Dec 27, 1989
DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095
K896006 · KOC
Baxter Healthcare Corp
Gastroenterology & Urology · 75d
Cleared Dec 27, 1989
AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
K895465 · JIH
Baxter Healthcare Corp
Chemistry · 107d
Cleared Dec 22, 1989
ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING
K895763 · KXO
Healthdyne Cardiovascular, Inc.
Obstetrics & Gynecology · 87d
Cleared Dec 22, 1989
TISSUE OXYGEN MONITOR SYSTEM, MODEL II
K890624 · CCE
Baxter Healthcare Corp
Anesthesiology · 318d
Cleared Dec 20, 1989
INFLATION PRO II
K895836 · MAV
Baxter Healthcare Corp
Cardiovascular · 78d
Cleared Dec 13, 1989
CURITY(R) DISPOSABLE LAPAROTOMY SPONGES
K896490 · EFQ
Kendall Healthcare Products Co....
General & Plastic Surgery · 30d
Cleared Dec 13, 1989
BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE
K895199 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 117d
Cleared Dec 07, 1989
CORTISOL TEST SYSTEM
K895421 · JFT
Baxter Healthcare Corp
Chemistry · 97d
Cleared Dec 06, 1989
VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY
K893646 · FPA
Baxter Healthcare Corp
General Hospital · 205d
Cleared Dec 05, 1989
MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM
K891121 · DYB
Boston Scientific Corp
Cardiovascular · 278d
Cleared Nov 30, 1989
DEVILBISS MODEL 6300D
K896090 · EPN
Devilbiss Health Care, Inc.
Ear, Nose, Throat · 42d
Cleared Nov 30, 1989
SCD KNEE IMMOBILIZER
K895278 · JOW
Kendall Healthcare Products Co....
Cardiovascular · 99d
Cleared Nov 29, 1989
TOWER SELF SEAL STERILIZATION POUCH
K895422 · JOJ
Baxter Healthcare Corp
General Hospital · 89d
Cleared Nov 29, 1989
KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN
K895352 · DWF
Kendall Healthcare Products Co....
Cardiovascular · 89d
Cleared Nov 27, 1989
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F
K894168 · DQO
Baxter Healthcare Corp
Cardiovascular · 165d
Cleared Nov 22, 1989
THE SHUTTLE (TM) THREE WHEEL SCOOTER
K896025 · INI
Pride Health Care, Inc.
Physical Medicine · 36d
Cleared Nov 17, 1989
LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX)
K893351 · LYY
China National Medicines & Health...
General Hospital · 210d
Cleared Nov 16, 1989
AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER*
K896434 · GEA
United States Surgical, A Division of...
General & Plastic Surgery · 7d
Cleared Nov 13, 1989
NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
K896321 · BSY
Superior Healthcare Group, Inc.
Anesthesiology · 12d