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
71857–71880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 14, 2003
URINE MONOVETTE BORIC ACID
K024237 · JSM
Sarstedt, Inc.
Microbiology · 112d
Cleared Apr 14, 2003
POLRIS LV
K030186 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 83d
Cleared Apr 14, 2003
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATES
K030362 · GEI
Leonhard Lang GmbH
General & Plastic Surgery · 70d
Cleared Apr 14, 2003
CERACAST-V
K030416 · EJH
Mountain Medico, Inc.
Dental · 63d
Cleared Apr 14, 2003
LINA-BAG, MODELS LB-60, LB-100
K030422 · GCJ
Lina Medical Cml Aps
General & Plastic Surgery · 63d
Cleared Apr 14, 2003
AT HOME DRUG CUP, MODEL 9150X
K030447 · MVO
Phamatech
Toxicology · 62d
Cleared Apr 14, 2003
PROANGLE DISPOSABLE PROPHY ANGLE
K030603 · EGS
Pac-Dent International (Suzhou), Ltd.
Dental · 48d
Cleared Apr 14, 2003
PASCO MIC AND MIC/ID PANELS
K030620 · LTT
Pasco Laboratories, Inc.
Microbiology · 46d
Cleared Apr 14, 2003
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
K030650 · CEN
Uridynamics, Inc.
Chemistry · 45d
Cleared Apr 14, 2003
PROTEC-TOP, STERIDENT, BENTO
K031022 · FRG
Ronpak, Inc.
General Hospital · 14d
Cleared Apr 11, 2003
GOLDWAY PATIENT MONITOR, MODEL # UT4000F
K021154 · MWI
Goldway Us, Inc.
Cardiovascular · 366d
Cleared Apr 11, 2003
SK MED M201 MIXER
K022864 · BZR
Sk Med
Anesthesiology · 226d
Cleared Apr 11, 2003
ONLINE DAT II CANNABINOIDS II
K030213 · LDJ
Roche Diagnostics Corp.
Toxicology · 80d
Cleared Apr 11, 2003
3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE...
K030270 · LJS
Medcomp
General Hospital · 74d
Cleared Apr 11, 2003
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN...
K030320 · JIS
Wako Chemicals USA, Inc.
Chemistry · 71d
Cleared Apr 11, 2003
AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)
K030340 · JQC
Cytomedix
Hematology · 70d
Cleared Apr 11, 2003
HL888HA
K030498 · DXN
Health & Life Co., Ltd.
Cardiovascular · 51d
Cleared Apr 11, 2003
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
K030555 · JQC
Biomet, Inc.
Hematology · 49d
Cleared Apr 11, 2003
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH,...
K030696 · DWF
Medtronic Perfusion Systems
Cardiovascular · 36d
Cleared Apr 11, 2003
RDI EXTENDED RANGE CRP CALIBRATOR SET
K030772 · JIT
Reference Diagnostics, Inc.
Immunology · 31d
Cleared Apr 11, 2003
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
K031003 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 11d
Cleared Apr 10, 2003
COOPERSURGICAL LAPAROSCOPIC INSTRUMENTS
K021237 · HET
CooperSurgical, Inc.
Obstetrics & Gynecology · 357d
Cleared Apr 10, 2003
CARE STIM
K022417 · GZJ
Care Rehab and Orthopaedic
Neurology · 260d
Cleared Apr 10, 2003
HYSTEREOSCOPY PUMP HM4
K022449 · HIG
W.O.M. World of Medicine AG
Obstetrics & Gynecology · 258d