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"
3409–3432 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 29, 1998
AIRWATCH II ZONELESS
K982675 · BZH
Enact Health Management Systems
Anesthesiology · 90d
Cleared Oct 28, 1998
MEPILEX
K983184 · MGP
Molnlycke Health Care, Inc.
General & Plastic Surgery · 47d
Cleared Oct 26, 1998
SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM...
K983197 · KWP
United States Surgical, A Division of...
Orthopedic · 45d
Cleared Oct 26, 1998
PATIENT WARMER- MODEL PW810
K982636 · ILY
Fisher &Paykel Healthcare , Ltd.
Physical Medicine · 89d
Cleared Oct 21, 1998
HOSPAL TIPSTOP
K982818 · KMF
Gambro Healthcare
General & Plastic Surgery · 71d
Cleared Oct 19, 1998
SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER,...
K983406 · FLL
Banta Healthcare Group, Ltd.
General Hospital · 21d
Cleared Oct 07, 1998
HEALTH CHECK URI-TEST PROTEIN IN URINE
K972960 · JIR
Tcpi, Inc.
Chemistry · 422d
Cleared Oct 05, 1998
VMT SYSTEM
K971549 · LXV
Target Health, Inc.
Ear, Nose, Throat · 525d
Cleared Sep 30, 1998
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON...
K982822 · CAK
Baxter Healthcare Corp
General Hospital · 50d
Cleared Sep 23, 1998
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
K974899 · FIP
Gambro Healthcare
Gastroenterology & Urology · 267d
Cleared Sep 14, 1998
LICHEN, BACTERIAL IN LINE BREATHING FILTER
K980662 · CAH
Dhd Healthcare Corp.
General Hospital · 206d
Cleared Sep 04, 1998
COLLEAGUE PUMP SYRINGE ADAPTER SET
K982672 · FPA
Baxter Healthcare Corp
General Hospital · 35d
Cleared Sep 04, 1998
SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5...
K982102 · MEB
Baxter Healthcare Corp
General Hospital · 81d
Cleared Aug 31, 1998
MP-3 POWER BASE CHAIR
K982066 · ITI
Merits Health Products., Inc.
Physical Medicine · 81d
Cleared Aug 24, 1998
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · FYC
Allegiance Healthcare Corp.
General Hospital · 48d
Cleared Aug 17, 1998
SOLUTION ADMINISTRATION SET
K981792 · FPA
Baxter Healthcare Corp
General Hospital · 88d
Cleared Aug 11, 1998
SCC-23 SAFETY CLAMP AND CUTTER
K982464 · KNA
Women First Healthcare, Inc.
Obstetrics & Gynecology · 27d
Cleared Aug 11, 1998
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K981681 · KDI
Gambro Healthcare
Gastroenterology & Urology · 90d
Cleared Aug 04, 1998
NASAL INTERFACE MODEL 7910
K974453 · BZD
Healthdyne Technologies, Inc.
Anesthesiology · 252d
Cleared Jul 26, 1998
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
K974445 · DRX
3M Healthcare
Cardiovascular · 243d
Cleared Jul 24, 1998
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K981774 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 65d
Cleared Jul 23, 1998
CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA...
K982269 · MIA
Allegiance Healthcare Corp.
Anesthesiology · 24d
Cleared Jul 10, 1998
CONVERTORS TRILAMINATE DRAPES
K981818 · KKX
Allegiance Healthcare Corp.
General Hospital · 49d
Cleared Jul 10, 1998
BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER
K974652 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 210d