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
105289–105312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 1994
FRAME, SPECTACLES
K945350 · HQZ
Taiwan Eva Industrial Co., Inc.
Ophthalmic · 90d
Cleared Dec 13, 1994
SHIELD, EYE, OPHTHALMIC
K945351 · HOY
Taiwan Eva Industrial Co., Inc.
Ophthalmic · 90d
Cleared Dec 13, 1994
WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE
K945805 · GEI
Wells Johnson Co.
General & Plastic Surgery · 15d
Cleared Dec 13, 1994
DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE
K945893 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 11d
Cleared Dec 13, 1994
ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES
K945898 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 11d
Cleared Dec 12, 1994
NEUROMED OCTRODE MODEL MNT-98 NEUROSTIMULATOR TRAN
K930498 · GZB
Neuromed, Inc.
Neurology · 679d
Cleared Dec 12, 1994
PRN ADAPTER
K933467 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 514d
Cleared Dec 12, 1994
DISPOSABLE DISC FILTER
K936015 · FMF
Medi-Dose, Inc.
General Hospital · 361d
Cleared Dec 12, 1994
ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS
K940230 · HRX
Instratek, Inc.
Orthopedic · 332d
Cleared Dec 12, 1994
FINESSE IEC/601
K941251 · HGI
Utah Medical Products, Inc.
Obstetrics & Gynecology · 272d
Cleared Dec 12, 1994
INVIRO SYRINGE
K941450 · MEG
Dr. F. Ross Sharp , Ltd.
General Hospital · 263d
Cleared Dec 12, 1994
PM9000 VAC TRAP
K941818 · KDQ
Precision Medical, Inc.
General Hospital · 243d
Cleared Dec 12, 1994
BES - BREATH EXPOSURE SYNCHRONIZER
K942581 · KPR
The Henry G. Dietz Co., Inc.
Radiology · 195d
Cleared Dec 12, 1994
CIBA CORNING ACS FOLATE ASSAY
K943297 · CGN
Ciba Corning Diagnostics Corp.
Chemistry · 157d
Cleared Dec 12, 1994
RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE
K943335 · JPK
R&D Systems, Inc.
Hematology · 153d
Cleared Dec 12, 1994
RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE
K943336 · JPK
R&D Systems, Inc.
Hematology · 153d
Cleared Dec 12, 1994
PLEXUS/1000
K943353 · FNM
Plexus Medical
General Hospital · 153d
Cleared Dec 12, 1994
UNIVEC NONRESUSABLE LOCKING SYRINGE
K943679 · FMI
Univec, Inc.
General Hospital · 139d
Cleared Dec 12, 1994
FLEXIFLO SIX ENTERAL NUTRITION PUMP
K943733 · LZH
Abbott Mfg., Inc.
General Hospital · 132d
Cleared Dec 12, 1994
LATEX MEDICAL GLOVE
K943900 · LYY
Johnson & Johnson Medical, Inc.
General Hospital · 124d
Cleared Dec 12, 1994
PURITAN-BENNETT DISPOSABLE MANUAL RESUSCITATOR (DMR)
K944347 · BTM
Puritan Bennett Corp.
Anesthesiology · 97d
Cleared Dec 12, 1994
I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS
K945522 · DFT
Beckman-Diagnostic Systems Group
Immunology · 32d
Cleared Dec 09, 1994
3400 INFUSION PUMP
K931318 · FRN
Graseby Medical , Ltd.
General Hospital · 633d
Cleared Dec 09, 1994
EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT
K935773 · JWH
Exactech, Inc.
Orthopedic · 371d