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
136465–136488 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 1988
EXCEL REGULAR SET
K875141 · DYH
Reliance Orthodontic Products, Inc.
Dental · 73d
Cleared Feb 26, 1988
RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE)
K875143 · DYH
Reliance Orthodontic Products, Inc.
Dental · 73d
Cleared Feb 26, 1988
EXCEL FAST SET
K875144 · DYH
Reliance Orthodontic Products, Inc.
Dental · 73d
Cleared Feb 26, 1988
MAR BOND
K875145 · EBG
Reliance Orthodontic Products, Inc.
Dental · 73d
Cleared Feb 26, 1988
DB PRECISION IMPLANT SYSTEM, 1000 SERIES W/HAC
K875242 · DZE
Driskell Bioengineering
Dental · 66d
Cleared Feb 26, 1988
DB PRECISION IMPLANT SYSTEM, 2000 SERIES W/HAC
K875243 · DZE
Driskell Bioengineering
Dental · 66d
Cleared Feb 26, 1988
BISCOLOR
K875256 · EBF
Bisco, Inc.
Dental · 66d
Cleared Feb 26, 1988
PROFESSIONAL SERIES BIOFEEDBACK DEVICES MODEL 421
K875308 · HCC
Self Regulation Systems, Inc.
Neurology · 59d
Cleared Feb 26, 1988
HOSKINS-BARKAN GONIOTOMY LENS 10MM
K875330 · HJK
Ocular Instruments, Inc.
Ophthalmic · 58d
Cleared Feb 26, 1988
BICONCAVE VITRECTOMY LENS
K875331 · HJK
Ocular Instruments, Inc.
Ophthalmic · 58d
Cleared Feb 26, 1988
LIDO(TM) LIFT
K880017 · IKK
Loredan Biomedical, Inc.
Physical Medicine · 52d
Cleared Feb 26, 1988
LIDO(TM) WORKSET
K880018 · IKK
Loredan Biomedical, Inc.
Physical Medicine · 52d
Cleared Feb 26, 1988
OKAMOTO CONDOMS
K880202 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 38d
Cleared Feb 26, 1988
ADDVANTAGE:TVC MARCON
K880284 · ESD
Richards Medical Co., Inc.
Ear, Nose, Throat · 32d
Cleared Feb 26, 1988
REPLICARE
K880299 · FRO
United Medical
General & Plastic Surgery · 32d
Cleared Feb 26, 1988
TORONTO/MOBILIMB HAND C.P.M.
K880686 · JFA
Toronto Medical Corp.
Physical Medicine · 7d
Cleared Feb 26, 1988
SURGICAL BURS
K880706 · GFF
Nuell Air Equipment & Hospital...
General & Plastic Surgery · 4d
Cleared Feb 25, 1988
IVAC(R) SITE-SAVER(R) VOLUMETRIC CONTROLLER - 280+
K874491 · LDR
Y
General Hospital · 115d
Cleared Feb 25, 1988
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11
K874767 · JAK
Shimadzu Precision Instruments, Inc.
Radiology · 98d
Cleared Feb 25, 1988
IR-192 IMPLANT
K874895 · IWA
Rads S.L., Inc.
Radiology · 86d
Cleared Feb 25, 1988
PROGENE(TM) IGE TEST
K875125 · DHB
Progene Corp.
Immunology · 72d
Cleared Feb 25, 1988
MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3
K880001 · DHB
3M Company
Immunology · 52d
Cleared Feb 25, 1988
MODIFIED CRP LATEX TEST
K880016 · DCK
Sclavo, Inc.
Immunology · 51d
Cleared Feb 25, 1988
EASY-TEST POTASSIUM K ITEM NUMBER 19XXX
K880339 · CEJ
Em Diagnostic Systems, Inc.
Chemistry · 30d