Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
158113–158136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1983
PRO-GUARD
K830739 · FRG
Surgicot, Inc.
General Hospital · 21d
Cleared Mar 29, 1983
HOT/ICE
K830757 · ILO
Thermo Temp, Inc.
Physical Medicine · 19d
Cleared Mar 29, 1983
ABBOTT PATIENT ASSIST DEVICE
K830766 · FKX
Abbott Laboratories
Gastroenterology & Urology · 19d
Cleared Mar 29, 1983
PULSETTE 110 TRANSCUTANEOUS ELEC-NERVE
K830792 · GZJ
Bomed Medical Mfr., Ltd.
Neurology · 15d
Cleared Mar 28, 1983
PHYSICIANS CHOICE SILICONE EAR PUTTY
K823921 · LDG
Santa Barbara Medco, Inc.
Ear, Nose, Throat · 90d
Cleared Mar 28, 1983
CART
K823925
Medical Assoc. Intl., Inc.
General & Plastic Surgery · 89d
Cleared Mar 28, 1983
C.A.T. REAGENT KIT
K830322 · JTQ
Remel Co.
Microbiology · 56d
Cleared Mar 25, 1983
CORSTREN COMPRESSION TUBE & PLATE
K830196 · KTT
Zimmer, Inc.
Orthopedic · 64d
Cleared Mar 25, 1983
PHADEZYM B2 MICRO TEST 100
K830280
Pharmacia, Inc.
Immunology · 58d
Cleared Mar 25, 1983
PDB II
K830289 · INQ
J.A. Gerber Therapeutical, Ltd.
Physical Medicine · 57d
Cleared Mar 25, 1983
CORNING 102 PRINTER
K830296 · JQP
Corning Medical & Scientific
Chemistry · 57d
Cleared Mar 24, 1983
AMBULATORY MARK I
K822842 · FRN
Windsor Medical, Inc.
General Hospital · 182d
Cleared Mar 24, 1983
DEVETHERM
K822873 · DQB
Eko Scann AB
Cardiovascular · 178d
Cleared Mar 24, 1983
PHYSIOLOGICAL PRESS. TRANSDUCER PCM3630
K823334 · DRS
Psitron
Cardiovascular · 136d
Cleared Mar 24, 1983
ELPHA 500
K823581 · GCJ
Prothia USA, Inc.
General & Plastic Surgery · 108d
Cleared Mar 24, 1983
PHADEBAS & PHADEZYM RAST TEST ALLERG
K823592 · DHB
Pharmacia, Inc.
Immunology · 108d
Cleared Mar 24, 1983
SAHOTA-KAPLAN HEMOSTAT
K823754 · DQO
Erickson Industries, Inc.
Cardiovascular · 100d
Cleared Mar 24, 1983
SCANLAN SINGLE-USE AORTA PUNCH
K823764 · DWS
Scanlan Intl., Inc.
Cardiovascular · 100d
Cleared Mar 24, 1983
IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242
K823878 · DXY
Pacesetter Systems
Cardiovascular · 87d
Cleared Mar 24, 1983
SURGICAL BLADES
K823905 · GEI
Designs IN Medicine
General & Plastic Surgery · 86d
Cleared Mar 24, 1983
SEPTOCAL
K830111
North Pacific Dental, Inc.
Dental · 72d
Cleared Mar 24, 1983
CARDIOVASCULAR SAW BLADES
K830189 · DWH
Temp Medical Products, Inc.
General & Plastic Surgery · 64d
Cleared Mar 24, 1983
API TB-IDENT*
K830211 · JSY
Analytical Products, Inc.
Microbiology · 59d
Cleared Mar 24, 1983
RIONET HEARING AID
K830236 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 58d