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
91369–91392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1997
KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER
K973476 · EHD
Eastman Kodak Company
Radiology · 56d
Cleared Nov 10, 1997
PHILIPS INTEGRIS V5000 AND BV5000
K973482 · IZI
Philips Medical Systems North...
Radiology · 56d
Cleared Nov 10, 1997
PLANMED CYTOGUIDE
K973493 · IZH
Planmed OY
Radiology · 56d
Cleared Nov 10, 1997
SIREMOBIL CO2
K973598 · OXO
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Nov 10, 1997
INFLATABLE POSITIONING CUSHIONS
K973915 · IZH
Kci New Technologies, Inc.
Radiology · 27d
Cleared Nov 10, 1997
ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K974075 · MMI
Beckman Instruments, Inc.
Chemistry · 12d
Cleared Nov 07, 1997
FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE
K962554 · KNT
Abbott Laboratories
Gastroenterology & Urology · 494d
Cleared Nov 07, 1997
SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM
K970081 · FNM
Cathay Consolidated, Inc.
General Hospital · 302d
Cleared Nov 07, 1997
O2 BOOT
K971507 · KPJ
Gwr Medical, Llp
General & Plastic Surgery · 196d
Cleared Nov 07, 1997
LOW PROFILE FEEDING SET ACCESSORY
K971757 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 178d
Cleared Nov 07, 1997
VERRESCOPE, LIGHT CABLE - LIGHT SOURCE ADAPTOR
K971836 · HET
CooperSurgical, Inc.
Obstetrics & Gynecology · 172d
Cleared Nov 07, 1997
GESCO PER-Q-CATH PICC CATHETERS
K971990 · FOZ
Bard Access Systems, Inc.
General Hospital · 182d
Cleared Nov 07, 1997
GESCO PER-Q-CATH MIDLINE CATHETERS
K971991 · FOZ
Bard Access Systems, Inc.
General Hospital · 182d
Cleared Nov 07, 1997
ACUITY CENTRAL STATION
K972121 · MLD
Protocol Systems, Inc.
Cardiovascular · 155d
Cleared Nov 07, 1997
STERI-OSS UNTIL IMPLANT CEMENT
K972965 · EMA
Steri-Oss, Inc.
Dental · 88d
Cleared Nov 07, 1997
MICRO21 WITH WBC ESTIMATE
K973050 · JOY
Triangle Biomedical Sciences, Inc.
Hematology · 84d
Cleared Nov 07, 1997
PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE)
K973058 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 81d
Cleared Nov 07, 1997
PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K973059 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 81d
Cleared Nov 07, 1997
KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING
K973068 · GCJ
Karl Storz Endoskop GmbH
General & Plastic Surgery · 81d
Cleared Nov 07, 1997
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE
K973301 · MEG
Retractable Technologies, Inc.
General Hospital · 66d
Cleared Nov 07, 1997
UNCOATED ELECTROSURGICAL ELECTRODE
K973346 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 63d
Cleared Nov 07, 1997
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
K973502 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 52d
Cleared Nov 07, 1997
KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
K973546 · EZD
Kendall Healthcare Products Co....
Gastroenterology & Urology · 50d
Cleared Nov 07, 1997
DURALASTIC ANATOMICAL CHIN IMPLANTS
K973575 · FWP
Hanson Medical, Inc.
General & Plastic Surgery · 49d