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"
4705–4728 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 06, 1988
ENDOSCOPIC ELASTIC BAND LIGATOR
K880648 · FHN
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 49d
Cleared Apr 06, 1988
MTI WOLFF SYSTEM
K881353 · LEJ
Health Systems Intl., Inc.
General & Plastic Surgery · 7d
Cleared Apr 01, 1988
EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR
K880052 · DTJ
Baxter Healthcare Corp
Cardiovascular · 86d
Cleared Mar 24, 1988
PARAMAX AMMONIA REAGENT
K880651 · JIF
Baxter Healthcare Corp
Chemistry · 36d
Cleared Mar 21, 1988
HEALTH CARE EYE PROTECTION
K875107 · HOY
Surgikos, Inc.
Ophthalmic · 98d
Cleared Mar 18, 1988
SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH
K880482 · FPA
Baxter Healthcare Corp
General Hospital · 42d
Cleared Mar 17, 1988
IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN
K880874 · GJT
Baxter Healthcare Corp
Hematology · 16d
Cleared Mar 16, 1988
DADE ANTITHROMBIN III CHROMOGENIC ASSAY
K880315 · JBQ
Baxter Healthcare Corp
Hematology · 50d
Cleared Mar 14, 1988
SANITARY MENSTRUAL NAPKIN
K875309 · HHD
Universal Health Care Products...
Obstetrics & Gynecology · 76d
Cleared Mar 11, 1988
HEALTHPHONE TOCO MODEL
K874631 · HFM
Carelink
Obstetrics & Gynecology · 122d
Cleared Mar 02, 1988
PHARMASEAL STERILE UMBILICAL CORD CLAMP
K875166 · HWI
Baxter Healthcare Corp
Orthopedic · 76d
Cleared Mar 02, 1988
DISPOSABLE DENTAL PROBE/EXPLORER
K880590 · EKJ
Baxter Healthcare Corp
Dental · 20d
Cleared Mar 01, 1988
DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL
K880175 · JJY
Baxter Healthcare Corp
Chemistry · 46d
Cleared Feb 29, 1988
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · DXC
United States Surgical, A Division of...
Cardiovascular · 82d
Cleared Feb 24, 1988
HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
K880650 · GCY
Baxter Healthcare Corp
General & Plastic Surgery · 7d
Cleared Feb 18, 1988
SARNS VENOATRIAL CATHETER
K875048 · DWF
3M Health Care, Sarns
Cardiovascular · 71d
Cleared Feb 16, 1988
ADCOMP 4000 HP SYSTEM
K874495 · LHI
Healthtek, Inc.
General Hospital · 106d
Cleared Feb 12, 1988
OXYGEN/PULSE MONITOR
K875031 · DQA
Healthdyne, Inc.
Anesthesiology · 67d
Cleared Feb 11, 1988
HEALTHDYNE RATE METER
K874814 · BZQ
Healthdyne, Inc.
Anesthesiology · 79d
Cleared Feb 09, 1988
CALIBRATION REFERENCE PLASMA
K874940 · GGP
Baxter Healthcare Corp
Hematology · 69d
Cleared Feb 05, 1988
ORTHODERM THERAPY BED
K874801 · FNM
Health Products, Inc.
General Hospital · 74d
Cleared Feb 04, 1988
AEROBICA - LUNG EXERCISER
K873540 · BWF
MBA Healthcare Products, Inc.
Anesthesiology · 156d
Cleared Feb 04, 1988
THROMBOPLASTIN.C
K874592 · GJS
Baxter Healthcare Corp
Hematology · 87d
Cleared Feb 04, 1988
EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES
K880205 · HRX
Baxter Healthcare Corp
Orthopedic · 16d