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
126481–126504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1990
PATIENT EXAMINATION GLOVES
K901479 · LYY
Hexza World Trade Sdn. Bhd.
General Hospital · 13d
Cleared Apr 06, 1990
SONICATH(TM) 5 F
K895542 · DQO
Boston Scientific Corp
Cardiovascular · 205d
Cleared Apr 06, 1990
DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
K900093 · EFB
Dentsply Intl.
Dental · 88d
Cleared Apr 05, 1990
DR. HERZBERG DISPOSABLE EXTERNAL FIXATOR
K890989 · KTT
Origin Medsystems, Inc.
Orthopedic · 401d
Cleared Apr 05, 1990
SALIVA ALCOHOL TEST
K894001 · DIC
Enzymatics C/O Burditt,Bowles,Radzius...
Chemistry · 304d
Cleared Apr 05, 1990
POINT CHECKER COLOR STRIP THERMOMETER
K894893 · FQZ
Kyowa Medex Co., Ltd.
General Hospital · 247d
Cleared Apr 05, 1990
RX02 EMERGENCY MEDICAL OXYGEN
K895956 · CAN
Progressive Medical Applications Corp.
Anesthesiology · 176d
Cleared Apr 05, 1990
SOLCOTRANS ORTHOPAEDIC DRAINAGE/REINFUSION SYSTEM
K896857 · CAC
Solco Basle, Inc.
Anesthesiology · 121d
Cleared Apr 05, 1990
SOLCOTRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM
K896858 · CAC
Solco Basle, Inc.
Anesthesiology · 121d
Cleared Apr 05, 1990
MODEL 20-CH CARBON DIOXIDE LASER W/ADD'L USES
K900253 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 78d
Cleared Apr 05, 1990
PROTEX LATEX EXAMINATION GLOVE
K900790 · LYY
Seyen Intl., Inc.
General Hospital · 44d
Cleared Apr 05, 1990
O.R. DATA MANAGER
K900937 · BSZ
Draeger Medical, Inc.
Anesthesiology · 36d
Cleared Apr 05, 1990
BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE
K901054 · LSR
Bion Ent., Ltd.
Microbiology · 30d
Cleared Apr 05, 1990
MODEL 8010
K901092 · LNH
Medical Advances, Inc.
Radiology · 29d
Cleared Apr 04, 1990
BONE PLATE
K893201 · HRS
Karlin Technology, Inc.
Orthopedic · 343d
Cleared Apr 04, 1990
BONE SCREW
K893203 · JDR
Karlin Technology, Inc.
Orthopedic · 343d
Cleared Apr 04, 1990
PROVIEW SELF-SEALING STERILIZATION POUCH
K893802 · KCT
Cottrell, Ltd.
General Hospital · 317d
Cleared Apr 04, 1990
SURGEON'S GLOVES
K894087 · KGO
Shangrila Latex Industries Pvt. , Ltd.
General Hospital · 300d
Cleared Apr 04, 1990
OSSEODENT DENTAL ATTACHMENTS
K895462 · DZE
Collagen Corp.
Dental · 210d
Cleared Apr 04, 1990
MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM
K895801 · DRT
Marquette Electronics, Inc.
Cardiovascular · 188d
Cleared Apr 04, 1990
ELATEC HOLTER ANALYZER
K895806 · DSI
Ela Medical, Inc.
Cardiovascular · 188d
Cleared Apr 04, 1990
RESUSO MASK
K895820 · BTM
Rml Ent., Inc.
Anesthesiology · 190d
Cleared Apr 04, 1990
SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN)
K895889 · EIH
Leach and Dillon Co., Inc.
Dental · 181d
Cleared Apr 04, 1990
VISITEC VITRECTOMY UNIT
K896622 · HKP
Visitec Co.
Ophthalmic · 134d