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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
122209–122232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1991
RHEUMAJET CRP
K910686 · DCN
Biokit USA, Inc.
Immunology · 28d
Cleared Mar 19, 1991
PANTEX IRMA LH 1251 KIT
K910717 · CEP
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 27d
Cleared Mar 19, 1991
TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH)
K910738 · DKZ
V-Tech, Inc.
Toxicology · 26d
Cleared Mar 19, 1991
SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE
K910768 · FGE
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 25d
Cleared Mar 19, 1991
ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE
K910875 · FDP
Ethicon, Inc.
General & Plastic Surgery · 18d
Cleared Mar 18, 1991
DEFIBRILLATOR ANALYZER MODEL QED-5
K904159 · DRL
Bio-Tek Instruments, Inc.
Cardiovascular · 188d
Cleared Mar 18, 1991
ZOEX ANTISHOCK TROUSERS
K904267 · JOW
Zoex Corp.
Cardiovascular · 181d
Cleared Mar 18, 1991
PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR
K904988 · DQA
Palco Laboratories, Inc.
Anesthesiology · 131d
Cleared Mar 18, 1991
PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT
K905067 · DSY
Pioneering Technologies, Inc.
Cardiovascular · 129d
Cleared Mar 18, 1991
ELECTROSURGICAL UNIT WITH ACCESSORIES
K905654 · GEI
Aspen Labs
General & Plastic Surgery · 90d
Cleared Mar 18, 1991
ACS ANGIOSCOPIC CATHETER
K905715 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 87d
Cleared Mar 18, 1991
CUSTOM ITE HEARING AID
K905784 · ESD
Hearing Aid Co.
Ear, Nose, Throat · 90d
Cleared Mar 18, 1991
DOSE CALIBRATOR
K905796 · KPT
Capintec Instruments, Inc.
Radiology · 81d
Cleared Mar 18, 1991
ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID
K910311 · ESD
Ototech, Ltd.
Ear, Nose, Throat · 53d
Cleared Mar 18, 1991
C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID
K910312 · ESD
Ototech, Ltd.
Ear, Nose, Throat · 53d
Cleared Mar 18, 1991
ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID
K910313 · ESD
Ototech, Ltd.
Ear, Nose, Throat · 53d
Cleared Mar 18, 1991
C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID
K910314 · ESD
Ototech, Ltd.
Ear, Nose, Throat · 53d
Cleared Mar 18, 1991
MEGA LACERATION KIT
K910368 · LRO
Megadyne Medical Products, Inc.
General & Plastic Surgery · 48d
Cleared Mar 15, 1991
KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP
K902193 · BTR
Kevtek Medical Products, Inc.
Anesthesiology · 303d
Cleared Mar 15, 1991
WIRON 99 DENTAL CASTING ALLOY
K903538 · EJH
Leach and Dillon Co., Inc.
Dental · 220d
Cleared Mar 15, 1991
DYNATRON 200 MICROCURRENT
K903577 · GZJ
Dynatronics Corp.
Neurology · 219d
Cleared Mar 15, 1991
STERAID DISPOSABLE SYRINGE
K904620 · FMF
Disposable Medi-Aids , Ltd.
General Hospital · 155d
Cleared Mar 15, 1991
BALLOON CATHETERS
K904669 · FGE
Olympus Corp.
Gastroenterology & Urology · 151d
Cleared Mar 15, 1991
BC-1201 CAST ABUTMENT
K904703 · DZE
Minimatic Implant Technology
Dental · 150d