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"
3457–3480 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 05, 1999
GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH
K990567 · FRG
Global Healthcare, Inc.
General Hospital · 41d
Cleared Apr 02, 1999
THERAPEP
K983467 · BWF
Dhd Healthcare Corp.
Anesthesiology · 189d
Cleared Apr 02, 1999
ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT...
K982505 · LYY
Tillotson Healthcare Corp.
General Hospital · 256d
Cleared Apr 01, 1999
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
K990952 · GAT
United States Surgical, A Division of...
General & Plastic Surgery · 10d
Cleared Apr 01, 1999
MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE
K990951 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 10d
Cleared Mar 26, 1999
GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS
K982414 · KDI
Gambro Healthcare
Gastroenterology & Urology · 256d
Cleared Mar 19, 1999
SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
K983572 · MNR
Healthdyne Technologies, Inc.
Anesthesiology · 157d
Cleared Mar 11, 1999
MABIS NB-02 ULTRASONIC NEBULIZER
K990506 · CAF
Mabis Healthcare, Inc.
Anesthesiology · 22d
Cleared Mar 03, 1999
MEPITEL NON ADHERENT SILICONE DRESSING
K984371 · MGP
Molnlycke Health Care, Inc.
General & Plastic Surgery · 86d
Cleared Mar 01, 1999
HYPERGEL 20% HYPERTONIC SALINE GEL
K984370 · MGQ
Molnlycke Health Care, Inc.
General & Plastic Surgery · 84d
Cleared Feb 24, 1999
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100...
K980386 · KDI
Gambro Healthcare
Gastroenterology & Urology · 387d
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