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
94537–94560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 1997
VENTANA ANTI-CD8 PRIMARY ANTIBODY
K941784 · DEH
Ventana Medical Systems, Inc.
Immunology · 1040d
Cleared Feb 14, 1997
S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
K960640 · HET
Wisap Gesellschaft Fur Wissenschaftl....
Obstetrics & Gynecology · 368d
Cleared Feb 14, 1997
EVENFLO NATURAL MOTHER ELECTRIC BREAST PUMP KIT
K960727 · HGX
Evenflo Co., Inc.
Obstetrics & Gynecology · 358d
Cleared Feb 14, 1997
SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M
K961246 · KRH
St. Jude Medical, Inc.
Cardiovascular · 319d
Cleared Feb 14, 1997
DSXL DIFFUSION SPIROMETER
K961252 · BTY
Inair , Ltd.
Anesthesiology · 319d
Cleared Feb 14, 1997
GRASEBY ANDERSEN'S, INTEGRITY S700
K963131 · BZG
Graseby Andersen
Anesthesiology · 186d
Cleared Feb 14, 1997
BALDUR VINYL POWDERED GLOVES
K963441 · LYZ
Hti Trading Group
General Hospital · 168d
Cleared Feb 14, 1997
TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM
K963505 · HHP
Tenet Medical Engineering
Obstetrics & Gynecology · 164d
Cleared Feb 14, 1997
VYGON BIONECTOR WITH EXTENSION SET
K963981 · FPA
Vygon Corp.
General Hospital · 134d
Cleared Feb 14, 1997
VASOVIEW BALLOON DISSECTION SYSTEM
K964171 · GCJ
Origin Medsystems, Inc.
General & Plastic Surgery · 119d
Cleared Feb 14, 1997
AMSEAL SURGICAL FACE MASK
K964358 · FXX
American Seal Co.
General Hospital · 105d
Cleared Feb 14, 1997
INFRASONICS ADULT VENTILATOR TRENDING OPTION
K964543 · CBK
Nellcor Puritan Bennett, Inc.
Anesthesiology · 93d
Cleared Feb 14, 1997
TRUSTEX COLA FLAVORD CONDOM
K964598 · HIS
Line One Laboratories
Obstetrics & Gynecology · 88d
Cleared Feb 14, 1997
TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR
K964599 · HIS
Line One Laboratories
Obstetrics & Gynecology · 88d
Cleared Feb 14, 1997
OASIS HUMIDIFIER
K964653 · BTT
Respironics, Inc.
Anesthesiology · 86d
Cleared Feb 14, 1997
OASIS
K964658 · ITX
Sonotech, Inc.
Radiology · 86d
Cleared Feb 14, 1997
SOFTOUCH
K964684 · GEX
Sahar Technologies, Inc.
General & Plastic Surgery · 84d
Cleared Feb 14, 1997
CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY
K964765 · KLT
Chiron Diagnostics Corp.
Toxicology · 79d
Cleared Feb 14, 1997
JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES
K964800 · LYZ
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 77d
Cleared Feb 14, 1997
PROD. NO. 01-132 - SUTURE REMOVAL KIT
K964827 · MCZ
Continental Medical Laboratories, Inc.
General & Plastic Surgery · 74d
Cleared Feb 14, 1997
FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS...
K964955 · OCY
Flexmedics
Gastroenterology & Urology · 65d
Cleared Feb 14, 1997
CYGNUS ELECTROSURGICAL TIP CLEANER
K965086 · GEI
Madison Polymeric Engineering
General & Plastic Surgery · 57d
Cleared Feb 14, 1997
DENTINSENSE B/C
K965138 · KLE
Centrix, Inc.
Dental · 53d
Cleared Feb 14, 1997
O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE
K965201 · LRO
Trinity Laboratories, Inc.
General & Plastic Surgery · 50d