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
124081–124104 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1990
VITA HI-CERAM
K902200 · EIH
Vident
Dental · 142d
Cleared Oct 05, 1990
RASTRONICS CCI 8
K902244 · ETW
Rastronics USA, Inc.
Ear, Nose, Throat · 140d
Cleared Oct 05, 1990
SMS-712NA
K903085 · GXW
Toshiba America Medical Systems, In.C
Neurology · 85d
Cleared Oct 05, 1990
LIQUID DETECTOR
K903495 · DXT
Life-Tech Intl., Inc.
Gastroenterology & Urology · 63d
Cleared Oct 05, 1990
TEMPOREX
K903551 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 60d
Cleared Oct 05, 1990
MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM
K903760 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 46d
Cleared Oct 05, 1990
MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL
K904358 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 11d
Cleared Oct 04, 1990
V SET
K900336 · FPA
Go Medical Industries Pty. , Ltd.
General Hospital · 254d
Cleared Oct 04, 1990
DYNATRON 350 EMG/BIOFEEDBACK ANALYZER
K900639 · HCC
Dynatronics Laser Corp.
Neurology · 237d
Cleared Oct 04, 1990
CYSTICERCOSIS SEROLOGICAL REAGENTS
K900780 · MDJ
Lmd Laboratories
Microbiology · 226d
Cleared Oct 04, 1990
LOW VOLUME BIFURCATED IV EXTENSION SET
K901088 · FPA
Marquette Medical, Inc.
General Hospital · 211d
Cleared Oct 04, 1990
LOW VOLUME TRIFURCATED IV EXTENSION SET
K901089 · FPA
Marquette Medical, Inc.
General Hospital · 211d
Cleared Oct 04, 1990
KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE
K901234 · KTT
Kirschner Medical Corp.
Orthopedic · 204d
Cleared Oct 04, 1990
IVAC(R) SYRINGE PUMP - MODEL 770
K901550 · FRN
Y
General Hospital · 184d
Cleared Oct 04, 1990
SUDORMED SWEAT PATCH SPECIMEN CONTAINER
K902442 · JKA
Sudormed, Inc.
Chemistry · 125d
Cleared Oct 04, 1990
SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)
K902575 · JIW
Diagnostic Products Corp.
Chemistry · 115d
Cleared Oct 04, 1990
FLEXOR (DENTURE ACRYLIC RELINE MATERIAL)
K902972 · EBI
Cmp Industries, LLC
Dental · 90d
Cleared Oct 04, 1990
ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM)
K903079 · GEX
Luxar Corp.
General & Plastic Surgery · 84d
Cleared Oct 04, 1990
SYNERMED CALCIUM REAGENT KIT
K903233 · CIC
Synermed, Inc.
Chemistry · 73d
Cleared Oct 04, 1990
STERILE URETHRAL CATHETER PROCEDURE KITS
K903340 · FCM
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 71d
Cleared Oct 04, 1990
SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
K903409 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 65d
Cleared Oct 04, 1990
LISS CRANIAL STIMULATOR MODEL SBL202-B
K903654 · QJQ
Medical Consultants Intl. , Ltd.
Neurology · 90d
Cleared Oct 04, 1990
CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY
K903665 · GKZ
Unipath , Ltd.
Hematology · 50d
Cleared Oct 04, 1990
CREATINE PHOSPHOKINASE
K903775 · CGS
Amresco, Inc.
Chemistry · 45d