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
127201–127224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 1990
FLEXI-CAST CROWN CORE SYSTEM
K896693 · ELR
Essential Dental Systems, Inc.
Dental · 78d
Cleared Feb 14, 1990
DYNASURG DENTAL IRRIGATION SYSTEM
K896890 · EFS
Micro Motors, Inc.
Dental · 68d
Cleared Feb 13, 1990
LEEDAR (PATIENT EXAMINATION GLOVES - LATEX)
K891663 · LYY
Darchet (Usa), Inc.
General Hospital · 330d
Cleared Feb 13, 1990
PATIENT EXAMINATION GLOVES (LATEX)
K892085 · LYY
Howard Associates, Inc.
General Hospital · 316d
Cleared Feb 13, 1990
CARDIOPULMONARY SUPPORT (CPS) SYSTEM
K892664 · DTZ
Bard Cardiosurgery Div
Cardiovascular · 306d
Cleared Feb 13, 1990
FLOUROSHIELD RADIATION REDUCTION GLOVE
K893093 · LZC
Acufex Microsurgical, Inc.
General Hospital · 306d
Cleared Feb 13, 1990
ADHESIVE BANDAGES & PADS FOR MINOR CUTS/SCRAPES
K893123 · QSY
Les Laboratorires Brothier, S.A.
General & Plastic Surgery · 294d
Cleared Feb 13, 1990
LATEX PATIENT EXAMINATION GLOVES
K894450 · LYY
Kannex Gloves, Div. of Kanoi...
General Hospital · 239d
Cleared Feb 13, 1990
BONEFIT HOLLOW CYLINDER IMPLANTS
K894593 · DZE
Institut Straumann AG
Dental · 204d
Cleared Feb 13, 1990
BONEFIT HOLLOW SCREW IMPLANTS
K894594 · DZE
Institut Straumann AG
Dental · 204d
Cleared Feb 13, 1990
BONEFIT R SCREW IMPLANTS
K894595 · DZE
Institut Straumann AG
Dental · 204d
Cleared Feb 13, 1990
MEDICARE GLOVES
K895021 · LYY
Shangrila Latex Industries Pvt. , Ltd.
General Hospital · 189d
Cleared Feb 13, 1990
MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
K895793 · DSH
Del Mar Avionics
Cardiovascular · 138d
Cleared Feb 13, 1990
LATEX PATIENT EXAMINATION GLOVE
K895902 · LYY
Rfb Latex Pvt. , Ltd.
General Hospital · 130d
Cleared Feb 13, 1990
ERBOTOM ACC 450
K896055 · GEI
Erbe Electromedizin GmbH
General & Plastic Surgery · 118d
Cleared Feb 13, 1990
MERCY HIP/KNEE PACK
K896215 · KKX
Westmark, Sterile Packing Systems,...
General Hospital · 110d
Cleared Feb 13, 1990
CO2 REAGENT (340 NM)
K896258 · KHS
Sigma Chemical Co.
Chemistry · 106d
Cleared Feb 13, 1990
BIOPSY PUNCH
K896303 · LRY
Premier Medical
General & Plastic Surgery · 106d
Cleared Feb 13, 1990
EOS IONIZED CALCIUM TEST CARD
K896316 · JFP
Eos Technology Corp.
Chemistry · 104d
Cleared Feb 13, 1990
NON-STERILE LATEX EXAMINATION GLOVES
K896363 · LYY
Contemporary Medical Technology, Inc.
General Hospital · 99d
Cleared Feb 13, 1990
LASERFLO BLOOD PERFUSION MONITOR, MODEL BPM2
K896515 · DPW
Tsi, Inc.
Cardiovascular · 90d
Cleared Feb 13, 1990
BISTAT ELECTROSURGICAL UNIT 60-5400-001
K896838 · GEX
Aspen Laboratories, Inc.
General & Plastic Surgery · 70d
Cleared Feb 13, 1990
DIGOXIN-EIA-XT
K896863 · KXT
In Vitro Diagnostics, Inc.
Toxicology · 69d
Cleared Feb 13, 1990
LUTEINIZING HORMONE-EIA-XT
K896866 · CEP
In Vitro Diagnostics, Inc.
Chemistry · 69d