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
82129–82152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 05, 2000
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
K001144 · HNO
Lasersight Technologies, Inc.
Ophthalmic · 25d
Cleared May 05, 2000
SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040
K001263 · GEX
E S C Sharplan
General & Plastic Surgery · 16d
Cleared May 05, 2000
MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH...
K001293 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 11d
Cleared May 05, 2000
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR...
K001310 · JFY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 10d
Cleared May 05, 2000
EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215...
K991293 · JOQ
Fischer Medical Technologies, Inc.
Cardiovascular · 386d
Cleared May 05, 2000
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
K991801 · MSV
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT
K991802 · MSV
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI B2 GP1 IGM EIA TEST KIT.
K991803 · MSV
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
BINDAZYME ANTI-B2 SCREEN EIA TEST KIT.
K991804 · MSV
The Binding Site, Ltd.
Immunology · 345d
Cleared May 05, 2000
THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
K993678 · JPA
Haemoscope Corp.
Hematology · 186d
Cleared May 05, 2000
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT...
K994243 · DWF
Heartport, Inc.
Cardiovascular · 141d
Cleared May 05, 2000
CONNECT DATA MANAGEMENT SYSTEM
K994433 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 127d
Cleared May 04, 2000
NOGA CARDIAC NAVIGATION SYSTEM
K000332 · DQK
Biosense Webster, Inc.
Cardiovascular · 91d
Cleared May 04, 2000
EYECAP IMAGING SYSTEM
K000368 · HKI
Clement Clarke Intl., Ltd.
Ophthalmic · 90d
Cleared May 04, 2000
SHUTTLE STOP
K000587 · LZN
Isotis NV
Orthopedic · 72d
Cleared May 04, 2000
VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT...
K000691 · HRX
Oratec Interventions, Inc.
Orthopedic · 65d
Cleared May 04, 2000
DIRECT TIBC CALIBRATOR
K000783 · JIT
Reference Diagnostics, Inc.
Chemistry · 55d
Cleared May 04, 2000
KAVO K.E.Y. LASER 1242
K000805 · GEX
Kavo America
General & Plastic Surgery · 52d
Cleared May 04, 2000
SHARP BRAND ACUPUNCTURE NEEDLES
K000816 · MQX
Tcm Supply Corp.
General Hospital · 52d
Cleared May 04, 2000
HTF-HEPES
K000939 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 42d
Cleared May 04, 2000
HUMAN SERUM ALBUMIN (HSA)
K000940 · MQL
Invitrocare, Inc.
Obstetrics & Gynecology · 42d
Cleared May 04, 2000
MULTI-PULSE 2000
K001248 · EHD
Imaging Sciences Intl., Inc.
Radiology · 16d
Cleared May 04, 2000
SIMPLEX AIRBRATOR (SAB-7)
K980672 · KOJ
Irt Management Corp.
Dental · 804d
Cleared May 04, 2000
MEDI-CULT FLUSHING MEDIUM
K991327 · MQL
Medicult A/S
Obstetrics & Gynecology · 381d