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
139585–139608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1987
BABY E.T. TAPE(TM)
K871560 · CBH
B&B Medical Technologies, Inc.
Anesthesiology · 30d
Cleared May 22, 1987
IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01
K871580 · DTB
Intermedics, Inc.
Cardiovascular · 29d
Cleared May 22, 1987
RF-1 CIRCUIT
K871592 · IZH
Diagnostic Imaging Specialists Corp.
Radiology · 28d
Cleared May 22, 1987
CSF-CARDIAC/PERITONEAL CATHETER
K871752 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 14d
Cleared May 22, 1987
MCCONNELL ORTHOPEDIC SHOULDER/HIP POSITIONER
K871819 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 11d
Cleared May 21, 1987
ENDOTRACHEAL TUBE HOLDER
K864526 · CBH
Mathew Medical Co.
Anesthesiology · 185d
Cleared May 21, 1987
IMPLANTABLE ELECTRODE LEAD, MODEL 030-439
K864618 · DTB
Telectronics, Inc.
Cardiovascular · 178d
Cleared May 21, 1987
CARHILL ONE-WAY RESUSCITATION VALVE
K864681 · CBP
Life Design Systems, Inc.
Anesthesiology · 170d
Cleared May 21, 1987
TRI-LEVEL LIGAND CONTROL
K864877 · DHX
Ciba Corning Diagnostics Corp.
Immunology · 160d
Cleared May 21, 1987
ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY
K870357 · DTB
Intermedics, Inc.
Cardiovascular · 112d
Cleared May 21, 1987
C150-P ECG CABLES
K870926 · DPS
Desco Industries, Inc.
Cardiovascular · 73d
Cleared May 21, 1987
STACHROM PROTEIN C TEST KIT
K871039 · GGP
American Bioproducts Co.
Hematology · 65d
Cleared May 21, 1987
SARNS 9000 HEART-LUNG CONSOLE
K871131 · DTQ
3M Health Care, Sarns
Cardiovascular · 62d
Cleared May 21, 1987
BIOSURGE MODEL OASYS
K871258 · CAC
Biosurge, Inc.
Anesthesiology · 51d
Cleared May 21, 1987
QM300 CALIBRATOR A PACK
K871341 · JIX
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 49d
Cleared May 21, 1987
QM2/QM300 CONTROL A PACK
K871342 · JJY
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 49d
Cleared May 21, 1987
SILVER STAIN REAGENT SYSTEM
K871476 · LEF
Sigma Chemical Co.
Pathology · 37d
Cleared May 21, 1987
MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER
K871625 · DTB
Intermedics, Inc.
Cardiovascular · 24d
Cleared May 21, 1987
GBNA MEDIUM
K871786 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 15d
Cleared May 20, 1987
S-CAL HEMATOLOGY CALIBRATOR
K862122 · KRY
Coulter Electronics, Inc.
Hematology · 351d
Cleared May 20, 1987
TYPE 316L COTTER WIRE
K864375 · LRN
Winn Hirsch & Assoc.
Orthopedic · 196d
Cleared May 20, 1987
PROPHYLACTIC (CONDOM) MR. JOHNNY
K865106 · HIS
Medelec Intl. Corp.
Obstetrics & Gynecology · 140d
Cleared May 20, 1987
ALLOY FOR DENTAL AMALGAM LUXALLOY NON GAMMA 2
K870230 · EJJ
Degussa Dental, Inc.
Dental · 119d
Cleared May 20, 1987
ABBOTT TESTPACK HCG COMBO
K870739 · JHI
Abbott Laboratories
Chemistry · 83d