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"
3385–3408 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 22, 1999
NORMLGEL 0.9% ISOTONIC SALINE GEL
K984368 · MGQ
Molnlycke Health Care, Inc.
General & Plastic Surgery · 77d
Cleared Feb 19, 1999
BURETROL SOLUTION SETS
K984381 · FPA
Baxter Healthcare Corp
General Hospital · 73d
Cleared Feb 10, 1999
SUPRASHIELD EXPRESS STERILIZATION WRAP
K990300 · FRG
Allegiance Healthcare Corp.
General Hospital · 9d
Cleared Feb 10, 1999
AUTO SUTURE SITE MARKER CLIP
K983400 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 135d
Cleared Feb 04, 1999
UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED)
K983614 · LYY
American Healthcare Products (M) Sdn Bhd
General Hospital · 113d
Cleared Jan 25, 1999
VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS
K981954 · NRQ
Healthline Implants, Inc.
Dental · 235d
Cleared Jan 21, 1999
ALLEGIANCE PORTA-WARM MATTRESS
K982652 · IMD
Allegiance Healthcare Corp.
Physical Medicine · 175d
Cleared Jan 14, 1999
TALKING DIGITAL THERMOMETER, MODEL KV-171
K984553 · FLL
K-Jump Health Co., Ltd.
General Hospital · 23d
Cleared Jan 12, 1999
MODIFICATION OF: RHEO DOPPLEX II
K984307 · IYN
Huntleigh Healthcare, Inc.
Radiology · 41d
Cleared Jan 08, 1999
ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES
K983962 · KGO
Cardinal Health-Medical Products and...
General Hospital · 63d
Cleared Jan 07, 1999
MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE
K984438 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 24d
Cleared Dec 30, 1998
ANTERIOR CERVICAL PLATING SYSTEM
K984342 · KWQ
United States Surgical, A Division of...
Orthopedic · 26d
Cleared Dec 22, 1998
ROGOZINSKI SPINAL ROD SYSTEM
K983904 · KWP
United States Surgical, A Division of...
Orthopedic · 49d
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