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
92617–92640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1997
MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS
K971607 · DQO
Boston Scientific Corp
Cardiovascular · 84d
Cleared Jul 24, 1997
PATTISON ESOPHAGEAL DILATOR
K971615 · KNQ
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 83d
Cleared Jul 24, 1997
DENTALIS KEZ ENDODONITC SEALER
K971642 · EMA
Neodental Chemical Products Co., Ltd.
Dental · 83d
Cleared Jul 24, 1997
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
K971668 · LNH
GE Medical Systems
Radiology · 79d
Cleared Jul 24, 1997
DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT
K971742 · FMQ
Depuy, Inc.
General Hospital · 73d
Cleared Jul 24, 1997
IMPLEX CONTINUUM POROUS PATELLAR
K971789 · JWH
Implex Corp.
Orthopedic · 71d
Cleared Jul 24, 1997
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
K971825 · JFJ
Randox Laboratories, Ltd.
Chemistry · 69d
Cleared Jul 24, 1997
CYTOLOGY BRUSH
K971849 · HHT
Team Technologies, Inc.
Obstetrics & Gynecology · 66d
Cleared Jul 24, 1997
CHOLESTECH BUN/CREATININE TEST SYSTEM
K972012 · CDN
Cholestech Corp.
Chemistry · 55d
Cleared Jul 24, 1997
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972170 · JPK
R&D Systems, Inc.
Hematology · 45d
Cleared Jul 24, 1997
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972172 · JPK
R&D Systems, Inc.
Hematology · 45d
Cleared Jul 24, 1997
PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.
K972338 · FMQ
Geriatric Products, Inc.
General Hospital · 31d
Cleared Jul 24, 1997
HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM
K972348 · ITX
Hewlett-Packard Co.
Radiology · 30d
Cleared Jul 24, 1997
CEDIA DIGOXIN CALIBRATORS
K972433 · DLJ
Boehringer Mannheim Corp.
Toxicology · 24d
Cleared Jul 24, 1997
RAMY INTEGRATED NEEDLE SYRINGE
K972452 · FMF
Alshifa Medical Syringes Mfg. Co., Ltd.
General Hospital · 78d
Cleared Jul 23, 1997
B SMART MODEL 1
K961817 · LEL
Koven Technology, Inc.
Neurology · 439d
Cleared Jul 23, 1997
STREP A OIA MAX
K962060 · GTZ
Biostar, Inc.
Microbiology · 421d
Cleared Jul 23, 1997
CAMOUFLAGE CUFF SAVERS
K963987 · DXQ
N.A. Braggs Medical, Inc.
Cardiovascular · 292d
Cleared Jul 23, 1997
POSEIDON CARDIAC MONITORING SYSTEM (PCMS)
K964408 · DPS
Instromedix, Inc.
Cardiovascular · 261d
Cleared Jul 23, 1997
TARGET 2 VERSION 1.1
K965010 · IYE
GE Medical Systems
Radiology · 219d
Cleared Jul 23, 1997
ULTIMA TPS CEMENTED STEM
K965198 · KWL
Johnson & Johnson International
Orthopedic · 209d
Cleared Jul 23, 1997
ENVOY GUIDING CATHETER
K965247 · DQY
Cordis Neurovascular, Inc.
Cardiovascular · 211d
Cleared Jul 23, 1997
INTRODUCER SHEATH AND DILATOR
K971165 · LDF
Boston Scientific Corp
Cardiovascular · 114d
Cleared Jul 23, 1997
BETTER HEARING, INC. MODEL L-1 HEARING AID
K971298 · ESD
Better Hearing, Inc.
Ear, Nose, Throat · 107d