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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91393–91416 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 1997
TELEMED SYSTEMS RETRIEVAL BASKET
K974300 · OCZ
Telemed Systems, Inc.
Gastroenterology & Urology · 32d
Cleared Dec 18, 1997
BOUSER'S URINAL
K970465 · EXJ
General Polymers
Gastroenterology & Urology · 314d
Cleared Dec 18, 1997
SHANG HO
K970795 · KGO
Shang HO Industrial Corp. , Ltd.
General Hospital · 289d
Cleared Dec 18, 1997
SNOREX
K971818 · LQZ
Snorex (Nz) , Ltd.
Dental · 216d
Cleared Dec 18, 1997
LATERAL FLARE INTERNAL COLLAR (LFIC)
K971900 · LWJ
Pro-Lfic, LLC
Orthopedic · 209d
Cleared Dec 18, 1997
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
K973284 · CHH
Roche Diagnostic Systems, Inc.
Chemistry · 107d
Cleared Dec 18, 1997
IDA-4 AND IPT-MC
K973609 · FRN
Bio-Tek Instruments, Inc.
General Hospital · 87d
Cleared Dec 18, 1997
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
K973614 · KWL
Encore Orthopedics, Inc.
Orthopedic · 86d
Cleared Dec 18, 1997
FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA
K973672 · JWH
Encore Orthopedics, Inc.
Orthopedic · 83d
Cleared Dec 18, 1997
BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED,...
K973682 · GEI
Electroscope, Inc.
General & Plastic Surgery · 83d
Cleared Dec 18, 1997
AQUA PATCH
K973693 · MGQ
Pci Technology
General & Plastic Surgery · 83d
Cleared Dec 18, 1997
DIGITAL ADD ON MULTI SYSTEM
K973710 · KPR
Swissray International, Inc.
Radiology · 80d
Cleared Dec 18, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K973913 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 65d
Cleared Dec 18, 1997
DASH, VITAL GARD
K974114 · LZA
Dash Medical Gloves Sdn Bhd
General Hospital · 48d
Cleared Dec 18, 1997
VINYL PATIENT EXAMINATION GLOVES (POWDERED)
K974151 · LYZ
Shanghai Super Gloves Co., Ltd.
General Hospital · 44d
Cleared Dec 18, 1997
SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
K974164 · FFK
Medical Device Consultants, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 18, 1997
POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)
K974183 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 42d
Cleared Dec 18, 1997
HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR)
K974184 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 42d
Cleared Dec 18, 1997
POLYMER NITRILE EXAMINATION GLOVES
K974185 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 42d
Cleared Dec 18, 1997
DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES
K974218 · LYY
Ansell Perry
General Hospital · 38d
Cleared Dec 18, 1997
NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES
K974223 · LZA
Derlin Company , Ltd.
General Hospital · 36d
Cleared Dec 18, 1997
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE...
K974396 · CHL
Diametrics Medical, Inc.
Hematology · 27d
Cleared Dec 18, 1997
CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004
K974454 · OCT
Tucson Medical Corp.
Gastroenterology & Urology · 23d
Cleared Dec 18, 1997
STERITITE SEALED CONTAINERS MODEL SCO4Q
K974638 · FRG
Case Medical, Inc.
General Hospital · 69d