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
166825–166848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 1980
MCGAW/EPIC I.V. ADMIN. SET
K800403 · FPA
American Hospital Supply Corp.
General Hospital · 50d
Cleared Apr 16, 1980
STEAROTHERMOHILUS SPORE STRIPS
K800482 · FRC
Mdt Corp., Inc.
General Hospital · 43d
Cleared Apr 16, 1980
SURGERY DISPLAY SYSTEM
K800488 · DRQ
Kent Barker & Assoc.
Cardiovascular · 43d
Cleared Apr 16, 1980
SHIELD LUCKY CAP
K800511 · FYF
American Convertors Div., American...
General & Plastic Surgery · 42d
Cleared Apr 16, 1980
SHIELD PERFECT FIT
K800528 · FXP
American Convertors Div., American...
General Hospital · 40d
Cleared Apr 16, 1980
SNYDER HYSTERECTOMY Y TUBE KIT
K800543 · GCY
Snyder Laboratories, Inc.
General & Plastic Surgery · 37d
Cleared Apr 16, 1980
HEPARIN PUMP #7420
K800570 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 33d
Cleared Apr 16, 1980
SNYDER HEMOVAC TM VENTED WOUND KIT
K800577 · GCY
Snyder Laboratories, Inc.
General & Plastic Surgery · 33d
Cleared Apr 16, 1980
SURGIVAC TM
K800578 · GCY
Snyder Laboratories, Inc.
General & Plastic Surgery · 33d
Cleared Apr 16, 1980
B-D STASET, I.V. FLOW CONTROLLER
K800600 · FPA
Bd Becton Dickinson Vacutainer...
General Hospital · 30d
Cleared Apr 16, 1980
MICROMEDIC AUTOMATIC DILUTER
K800606 · JQW
Micromedic Systems
Chemistry · 30d
Cleared Apr 16, 1980
CYBERLITH IMPLANTABLE PULSE GEN. #253-02
K800644 · DXY
Intermedics, Inc.
Cardiovascular · 23d
Cleared Apr 16, 1980
NORSEN DEBRIDER
K800647 · GEN
Medline Industries, Inc.
General & Plastic Surgery · 23d
Cleared Apr 16, 1980
MODEL 100 SPECTRAVIEW
K800655 · DQC
Edwards Laboratories
Cardiovascular · 22d
Cleared Apr 16, 1980
FERRITIN CONTROLS CODE QAS.104
K800657 · DBF
Amersham Corp.
Immunology · 22d
Cleared Apr 16, 1980
RST-SERIES CONTROL
K800658 · KSF
Gamma Biologicals, Inc.
Microbiology · 21d
Cleared Apr 16, 1980
MONITEMP BLOOD PACK TEMP. MONITOR
K800667 · KSE
Liquid Crystal Products, Inc.
Hematology · 21d
Cleared Apr 16, 1980
SMAC REPLACEMENT REAGENTS, WETTING AGENT
K800670
Diagnostic Solutions, Inc.
Chemistry · 21d
Cleared Apr 16, 1980
SMAC REPLACEMENT REAGENTS-WASH SOLUTIONS
K800671
Diagnostic Solutions, Inc.
Chemistry · 21d
Cleared Apr 16, 1980
STANBIO PROSTATIC ACID PHOSPHATASE TEST
K800693 · CKE
Stanbio Laboratory
Chemistry · 20d
Cleared Apr 16, 1980
AMERLEX CORTISOL RIA KIT
K800700 · CGR
Amersham Corp.
Chemistry · 19d
Cleared Apr 16, 1980
MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO
K800705 · DRS
Graphic Controls Corp.
Cardiovascular · 16d
Cleared Apr 16, 1980
MEDI-TRACE DISPOSABLE DOMES/MONITORING
K800706 · DRS
Graphic Controls Corp.
Cardiovascular · 16d
Cleared Apr 16, 1980
CODE QAS.105 PROLACTIN CONTROL SERA
K800708 · JJX
Amersham Corp.
Chemistry · 16d