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
81433–81456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2000
DR180-II
K001288 · MWJ
North East Monitoring, Inc.
Cardiovascular · 87d
Cleared Jul 20, 2000
STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
K001306 · DQD
Andromed, Inc.
Cardiovascular · 86d
Cleared Jul 20, 2000
CPAP SYSTEM, MODEL 102001
K001318 · BYE
Sims Portex, Inc.
Anesthesiology · 85d
Cleared Jul 20, 2000
MODIFICATION TO OMEGA 21 SYSTEM
K001357 · KWQ
Ebi, L.P.
Orthopedic · 83d
Cleared Jul 20, 2000
TI-MAX PROTRUSIO CAGE
K001376 · JDI
Biomet, Inc.
Orthopedic · 80d
Cleared Jul 20, 2000
SYNTHES CERVIFIX SYSTEM
K001864 · KWQ
Synthes Spine
Orthopedic · 30d
Cleared Jul 20, 2000
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS...
K001885 · CDN
Ortho-Clinical Diagnostics, Inc.
Chemistry · 29d
Cleared Jul 20, 2000
MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
K001930 · DQA
Nonin Medical, Inc.
Anesthesiology · 24d
Cleared Jul 20, 2000
TORNIER CEMENT RESTRICTOR
K001932 · JDI
Tornier
Orthopedic · 24d
Cleared Jul 20, 2000
REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER...
K001966 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 22d
Cleared Jul 20, 2000
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
K002126 · FRN
Abbott Laboratories
General Hospital · 6d
Cleared Jul 20, 2000
MEDI-CULT UNIVERSAL IVF-MEDIUM
K991279 · MQL
Medicult A/S
Obstetrics & Gynecology · 463d
Cleared Jul 20, 2000
BOOKER BOX, MODEL PAD 5010
K993205 · LDD
Tz Medical, Inc.
Cardiovascular · 300d
Cleared Jul 19, 2000
LA PERSONAL SCOOTER
K000869 · INI
Assembled Products Corp.
Physical Medicine · 124d
Cleared Jul 19, 2000
THERMAGE THERMACOOL SYSTEM
K000944 · GEI
Thermage, Inc.
General & Plastic Surgery · 118d
Cleared Jul 19, 2000
JILCO TRACTION-FLEXION CHAIR
K001361 · ITH
Jilco Enterprises
Physical Medicine · 82d
Cleared Jul 19, 2000
O-LAS OPHTHALMIC PHOTODISRUPTOR
K001511 · GEX
A.R.C. Laser AG
General & Plastic Surgery · 65d
Cleared Jul 19, 2000
KSEA BIPOLAR COAGULATING ELECTRODES
K001630 · GWG
Karl Storz Endoscopy
Neurology · 54d
Cleared Jul 19, 2000
REDON SET
K001716 · JCX
Pfm Produkte Fur Die Medizin AG
General & Plastic Surgery · 44d
Cleared Jul 19, 2000
COOL-TEC ELECTRODES
K001723 · GEI
Seedling Enterprises., LLC
General & Plastic Surgery · 43d
Cleared Jul 19, 2000
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)
K001746 · GEX
Coherent Star
General & Plastic Surgery · 41d
Cleared Jul 19, 2000
MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001751 · LLZ
Barco NV Display Systems
Radiology · 41d
Cleared Jul 19, 2000
MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001752 · LLZ
Barco NV Display Systems
Radiology · 41d
Cleared Jul 19, 2000
MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K001754 · LLZ
Barco NV Display Systems
Radiology · 41d