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
81361–81384 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 2000
PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
K001984 · JDG
Stelkast Company
Orthopedic · 90d
Cleared Sep 27, 2000
SURGITRON IEC II
K001986 · GEI
Ellman Intl., Inc.
General & Plastic Surgery · 90d
Cleared Sep 27, 2000
ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART
K002039 · LLZ
Cti Pet Systems, Inc.
Radiology · 84d
Cleared Sep 27, 2000
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY
K002146 · LMC
Eastman Kodak Company
Radiology · 72d
Cleared Sep 27, 2000
WIRE, GUIDE, CATHETER, MODEL QSW1000
K002346 · DQX
Medtronic Ave, Inc.
Cardiovascular · 56d
Cleared Sep 27, 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K002399 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 51d
Cleared Sep 27, 2000
COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE
K002767 · DXC
Semler Technologies, Inc.
Cardiovascular · 21d
Cleared Sep 27, 2000
TYSHAK, MODEL 102 AND Z-MED, MODEL 302
K991977 · LIT
NuMED, Inc.
Cardiovascular · 474d
Cleared Sep 26, 2000
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM
K000095 · LFL
The Olympus Optical Co.
General & Plastic Surgery · 257d
Cleared Sep 26, 2000
CONSTELLATION CATHETERS
K000277 · MTD
Boston Scientific Corp
Cardiovascular · 239d
Cleared Sep 26, 2000
OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
K000512 · DXQ
Cas Medical Systems, Inc.
Cardiovascular · 223d
Cleared Sep 26, 2000
DRX HBA1C - FOR PRESCRIPTION HOME USE
K000885 · LCP
Metrika, Inc.
Hematology · 190d
Cleared Sep 26, 2000
BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
K001022 · JZG
Biocheck, Inc.
Immunology · 180d
Cleared Sep 26, 2000
BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
K001244 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 161d
Cleared Sep 26, 2000
BN PROSPEC SYSTEM
K001647 · JZW
Dade Behring, Inc.
Immunology · 119d
Cleared Sep 26, 2000
JET 1 POWERED WHEELCHAIR
K001970 · ITI
Pride Mobility Products Corp.
Physical Medicine · 90d
Cleared Sep 26, 2000
OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES
K002030 · MWI
Invivo Research, Inc.
Cardiovascular · 85d
Cleared Sep 26, 2000
FREEZER TEETHER
K002066 · KKO
Cool Baby, Inc.
Dental · 81d
Cleared Sep 26, 2000
ATAC PAK ALP REAGENT KIT
K002285 · CJE
Elan Diagnostics
Chemistry · 62d
Cleared Sep 26, 2000
SUPER 6
K002300 · EJH
Dental Alloy Products, Inc.
Dental · 60d
Cleared Sep 26, 2000
SUPER 14
K002302 · EJH
Dental Alloy Products, Inc.
Dental · 60d
Cleared Sep 26, 2000
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
K002354 · KHS
Diagnostic Chemicals , Ltd.
Toxicology · 55d
Cleared Sep 26, 2000
CLOUD CUFF
K002360 · DXQ
Parts Port, Ltd.
Cardiovascular · 54d
Cleared Sep 26, 2000
HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT
K002461 · EMA
Shofu Dental Corp.
Dental · 47d