FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,281 results for "health"
3481–3504 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 22, 1998
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
K983899 · KWQ
United States Surgical, A Division of...
Orthopedic · 49d
Cleared Dec 16, 1998
AUTO SUTURE LAPAROSCOPES DEVICE
K983293 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 86d
Cleared Dec 08, 1998
MAXVIEW DIAGNOSTIC WORKSTATION
K984023 · LLZ
Dynamic Healthcare Technologies, Inc.
Radiology · 26d
Cleared Nov 30, 1998
NITRILE POWDER-FREE UNISEAL GLOVES
K982218 · LZA
American Healthcare Products (M) Sdn Bhd
General Hospital · 159d
Cleared Nov 30, 1998
UNISEAL GLOVES LOW PROTEIN POWDERED
K981979 · LYY
American Healthcare Products (M) Sdn Bhd
General Hospital · 178d
Cleared Nov 10, 1998
ALLDRESS, ABSORBENT FILM DRESSING
K983554 · KMF
Molnlycke Health Care, Inc.
General & Plastic Surgery · 28d
Cleared Nov 10, 1998
RESPIRATORY HUMIDIFIER, MODEL # MR850
K983112 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 67d
Cleared Nov 06, 1998
MESH, SURGICAL, POLYMERIC
K982575 · FTL
United States Surgical, A Division of...
General & Plastic Surgery · 105d
Cleared Nov 04, 1998
COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET
K982760 · KDI
Gambro Healthcare
Gastroenterology & Urology · 90d
Cleared Nov 03, 1998
ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152,...
K983294 · KPE
Baxter Healthcare Corp
General Hospital · 43d
Cleared Oct 29, 1998
AIRWATCH II ZONE
K982676 · BZH
Enact Health Management Systems
Anesthesiology · 90d
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