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
81937–81960 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 2000
LIGHT-CURED ORTHODONTIC BAND CEMENT
K001446 · DYH
Scientific Pharmaceuticals, Inc.
Dental · 74d
Cleared Jul 21, 2000
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K001530 · JEY
Bioplate, Inc.
Dental · 65d
Cleared Jul 21, 2000
MINICAM
K001541 · EIA
Video Dental Concepts, Inc.
Dental · 65d
Cleared Jul 21, 2000
MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM
K001750 · LLZ
Barco NV Display Systems
Radiology · 43d
Cleared Jul 21, 2000
TAKE 1 BITE
K001876 · ELW
Sybron Dental Specialties, Inc.
Dental · 31d
Cleared Jul 21, 2000
MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
K002046 · DXN
Vsm Technology, Inc.
Cardiovascular · 16d
Cleared Jul 21, 2000
PROTON BEAM THERAPY SYSTEM (PBTS)
K992414 · LHN
Optivus Technology, Inc.
Radiology · 367d
Cleared Jul 21, 2000
CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510
K994141 · MJN
Medtronic Ave, Inc.
Cardiovascular · 226d
Cleared Jul 20, 2000
PTA BALLOON CATHETER
K001087 · LIT
Cook, Inc.
Cardiovascular · 107d
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