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
83689–83712 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1999
ACCU-CHEK SIMPLICITY SYSTEM
K993829 · LFR
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Dec 08, 1999
NEXFLEX TOTAL KNEE SYSTEM
K991882 · JWH
Nexmed, Inc.
Orthopedic · 189d
Cleared Dec 08, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT...
K992595 · MHX
Hewlett-Packard GmbH
Cardiovascular · 127d
Cleared Dec 08, 1999
V-DELTA SPECIAL, ALLOY NO. 5154
K993505 · EJS
Metalor Dental USA Corp.
Dental · 54d
Cleared Dec 08, 1999
PAGALINOR 4 , ALLOY NO. 5440
K993506 · EJS
Metalor Dental USA Corp.
Dental · 54d
Cleared Dec 08, 1999
HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM
K993766 · MUJ
Helax AB
Radiology · 30d
Cleared Dec 07, 1999
BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE
K984168 · FCF
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 382d
Cleared Dec 07, 1999
PHILIPS EASYVISION WORKSTATION
K990329 · LNH
Philips Medical Systems North...
Radiology · 308d
Cleared Dec 07, 1999
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
K990643 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 284d
Cleared Dec 07, 1999
VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE
K991706 · HAW
Stryker Corp.
Neurology · 202d
Cleared Dec 07, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K993299 · GKP
Dade Behring, Inc.
Hematology · 67d
Cleared Dec 07, 1999
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
K993774 · DXT
Acist Medical Systems
Cardiovascular · 29d
Cleared Dec 07, 1999
BIONIKE AQ PHENCYCLIDINE (PCP) TEST
K993945 · LCM
Bionike Laboratories, Inc.
Toxicology · 18d
Cleared Dec 06, 1999
OPTISTAR MR INJECTOR SYSTEM
K984088 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 385d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140
K990110 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570
K990111 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610
K990112 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND...
K990113 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440
K990115 · DRX
Maersk Medical A/S
Cardiovascular · 327d
Cleared Dec 06, 1999
TYRODE'S SOLUTION-ACIDIFIED
K991339 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 231d
Cleared Dec 06, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY,...
K992188 · JNM
Nichols Institute Diagnostics
Immunology · 160d
Cleared Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
K992711 · GFO
Sigma Diagnostics, Inc.
Hematology · 117d
Cleared Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
K992712 · GFO
Sigma Diagnostics, Inc.
Hematology · 117d
Cleared Dec 06, 1999
COLON ALERT TEST
K992759 · KHE
Immunostics Inc.,
Hematology · 111d