FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
91969–91992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 1997
RESUABLE HOT BIOPSY FORCEPS
K972505 · KGE
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 77d
Cleared Sep 18, 1997
PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS
K972527 · FPA
Quality System Consulting
General Hospital · 73d
Cleared Sep 18, 1997
S-357 VIDEO IMAGING SYSTEM
K972540 · FET
Sopro
Gastroenterology & Urology · 73d
Cleared Sep 18, 1997
AURELUX BIO Y85PF
K972949 · EJT
Aurex Precious Metal Industries (Pty)Ltd
Dental · 90d
Cleared Sep 18, 1997
PROSTATE SPECIFIC ANTIGEN METHOD
K973101 · LTJ
Dade Chemistry Systems, Inc.
Immunology · 30d
Cleared Sep 17, 1997
MICROETCHER AP
K970589 · KOJ
Danville Engineering, Inc.
Dental · 211d
Cleared Sep 17, 1997
GLUCOSITE TEST SYSTEM
K971145 · CGA
Gds Technology, LLC
Chemistry · 173d
Cleared Sep 17, 1997
RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
K971508 · KIR
Bio-Whittaker, Inc., A Cambrex Co.
Microbiology · 145d
Cleared Sep 17, 1997
SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT
K972283 · BTM
Sims
Anesthesiology · 90d
Cleared Sep 17, 1997
ACS HI-TORQUE RULER GUIDE WIRE
K972290 · DQX
Guidant Corp.
Cardiovascular · 90d
Cleared Sep 17, 1997
BIG BEN SQUARE, BIG BEN ROUND
K972301 · DXQ
Rudolf Riester GmbH & Co. KG
Cardiovascular · 90d
Cleared Sep 17, 1997
THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM
K972417 · DZE
Bicon, Inc.
Dental · 82d
Cleared Sep 17, 1997
IPS EMPRESS COSMO INGOT
K972827 · EIH
Ivoclar North America, Inc.
Dental · 49d
Cleared Sep 17, 1997
SUNGLASSES
K972850 · HQY
Indoptica, S.A.
Ophthalmic · 47d
Cleared Sep 17, 1997
COSMOPOST
K972875 · ELR
Ivoclar North America, Inc.
Dental · 44d
Cleared Sep 17, 1997
NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS
K973016 · HQY
Optimaxx Intl.
Ophthalmic · 35d
Cleared Sep 16, 1997
8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT...
K963865 · DSP
Arrow Intl., Inc.
Cardiovascular · 357d
Cleared Sep 16, 1997
HANDIFLEX
K971046 · JFB
Handiflex Corp.
Physical Medicine · 179d
Cleared Sep 16, 1997
OPPORTUNITY INCISION AND DRAINAGE TRAY
K971088 · EFQ
Opportunity, Inc.
General & Plastic Surgery · 176d
Cleared Sep 16, 1997
OPPORTUNITY, INC. LACERATION TRAY
K971089 · KKX
Opportunity, Inc.
General Hospital · 176d
Cleared Sep 16, 1997
OPPORTUNITY DRESSING CHANGE TRAY
K971090 · KMF
Opportunity, Inc.
General & Plastic Surgery · 176d
Cleared Sep 16, 1997
OPPURTUNITY TRACHEOSTOMY CARE KIT
K971091 · KMF
Opportunity, Inc.
General & Plastic Surgery · 176d
Cleared Sep 16, 1997
OPPORTUNITY I.V. START KIT
K971093 · MGP
Opportunity, Inc.
General & Plastic Surgery · 176d
Cleared Sep 16, 1997
OPPORTUNITY SUTURE REMOVAL KIT
K971095 · EFQ
Opportunity, Inc.
General & Plastic Surgery · 176d