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"
4993–5016 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 03, 1981
NICHOLAS II, VIRAL-BACTERIAL FILTER
K811546 · CAH
K & G Healthcare Ind., Inc.
General Hospital · 63d
Cleared Jul 31, 1981
JAPANESE HOTZIE
K811803 · IMD
Consolidated Health & Sports Prod.
Physical Medicine · 37d
Cleared Jul 27, 1981
CUSTOM IN-THE-EAR HEARING AID
K811719 · ESD
Hearing Health Group, Inc.
Ear, Nose, Throat · 39d
Cleared Jul 27, 1981
OXY-QUIK MARK IV OXYGEN INHALATOR
K811987 · DRM
Oxequip Health Ind.
Cardiovascular · 14d
Cleared Jul 10, 1981
SILASTIC TENDON PASSER H.P.
K811679 · HWQ
Dow Corning Corp. Healthcare...
Orthopedic · 25d
Cleared Jun 12, 1981
AUTO-SYRINGE MICRO VOLUME EXTENSION SET
K811463 · FPA
Baxter Healthcare Corp
General Hospital · 17d
Cleared May 27, 1981
BARALYME CO2 ABSORBENT
K811260 · CBL
Allied Healthcare Products, Inc.
Chemistry · 21d
Cleared May 08, 1981
HOME HEALTH CHEKUP KIT
K810488 · KHE
Healthkit
Hematology · 74d
Cleared Apr 23, 1981
MASS SPECTROMETER-MEDSPECT II
K810938 · DOP
Allied Healthcare Products, Inc.
Toxicology · 16d
Cleared Apr 23, 1981
NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI.
K810939 · BTT
Allied Healthcare Products, Inc.
Anesthesiology · 16d
Cleared Apr 14, 1981
RESPIRATORY INTENSIVE CARE SYSTEM (RICS)
K810927 · CCK
Allied Healthcare Products, Inc.
Anesthesiology · 8d
Cleared Apr 10, 1981
X-RAY COLLIMATING DEVICES
K810598 · IZW
Midmark Corp.
Radiology · 35d
Cleared Apr 08, 1981
ANIMAL SERUM PRODUCTS
K810478 · KIS
Animal Health Laboratories, Inc.
Toxicology · 44d
Cleared Mar 24, 1981
SARA
K810585 · CBS
Allied Healthcare Products, Inc.
Anesthesiology · 20d
Cleared Mar 20, 1981
AUTO SUTURE PSS SKIN STAPLING INSTRUMENT
K810187 · KBC
United States Surgical, A Division of...
Ear, Nose, Throat · 57d
Cleared Mar 20, 1981
AUTO SUTURE GAS POWERED DISP. LDS STAPL
K810188 · KBC
United States Surgical, A Division of...
Ear, Nose, Throat · 57d
Cleared Mar 17, 1981
SARNS TWO-STATE WIRE REINFORCED CATHETER
K810415 · DWF
3M Health Care, Sarns
Cardiovascular · 27d
Cleared Mar 13, 1981
GOMCO SUCTION PUMP CABINET CHANGE
K810490 · BTA
Allied Healthcare Products, Inc.
General & Plastic Surgery · 17d
Cleared Mar 05, 1981
SARNS MINI-SUCKER
K810416 · GCY
3M Health Care, Sarns
General & Plastic Surgery · 15d
Cleared Mar 04, 1981
PROCEDURE & RECOVERY PATIENT SUIT
K803171 · FYB
Alba Health Care
General Hospital · 79d
Cleared Mar 04, 1981
PERCUTANEOUS GASTROINTESTINAL TUBE
K810499 · KNT
Health Development Corp.
Gastroenterology & Urology · 8d
Cleared Feb 12, 1981
MEAN PRESSURE MONITOR
K810255 · CAP
Healthdyne, Inc.
Anesthesiology · 13d
Cleared Feb 04, 1981
STAT-CRIT HEMATOCRIT MEASURING INSTRU
K802199 · GKF
United States Surgical, A Division of...
Hematology · 147d
Cleared Jan 30, 1981
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
K810079 · KRI
3M Health Care, Sarns
Cardiovascular · 17d