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
126409–126432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1990
SEARS MODEL LS9093 IN-THE-EAR HEARING INSTRUMENT
K901386 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 18d
Cleared Apr 13, 1990
LASER LAPAROSCOPIC CHOLECYSTECTOMY
K901541 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 10d
Cleared Apr 12, 1990
GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP
K897119 · HQW
Grieshaber & Co.
Ophthalmic · 107d
Cleared Apr 12, 1990
CONNECT
K900303 · EMA
Parkell
Dental · 80d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
K900702 · LGI
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR
K900703 · LCD
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA
K900704 · LGQ
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR
K900705 · LBZ
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA
K900706 · LGS
Innotron of Oregon, Inc.
Toxicology · 59d
Cleared Apr 12, 1990
CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO)
K901137 · CEO
Technicon Instruments Corp.
Chemistry · 31d
Cleared Apr 12, 1990
QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD
K901453 · DFT
Isolab, Inc.
Immunology · 16d
Cleared Apr 11, 1990
ULTRASCAN(R)
K896173 · IYO
Topical Delivery Systems
Radiology · 168d
Cleared Apr 11, 1990
ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST
K896493 · LQF
Gen-Probe, Inc.
Microbiology · 149d
Cleared Apr 11, 1990
DU PONT VISTA(R) IMMUNOASSAY SYSTEM
K900245 · JJQ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 84d
Cleared Apr 11, 1990
ENZYMUN TEST(R) TSH-S
K900277 · JLW
Boehringer Mannheim Corp.
Chemistry · 82d
Cleared Apr 11, 1990
IST-200 INTERSEGMENTAL TRACTION TABLE
K900304 · JFB
Chattanooga Group, Inc.
Physical Medicine · 80d
Cleared Apr 11, 1990
AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583
K900394 · CDQ
American Research Products Co.
Chemistry · 72d
Cleared Apr 11, 1990
AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500
K900977 · CEO
American Research Products Co.
Chemistry · 39d
Cleared Apr 11, 1990
ORTHO ABNORMAL PROTEIN C CONTROL PLASMA
K901233 · GGC
Ortho Diagnostic Systems, Inc.
Hematology · 28d
Cleared Apr 11, 1990
LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM
K901271 · DIF
Bio-Rad
Toxicology · 23d
Cleared Apr 10, 1990
MODIFIED DPX BONE DENSITOMETER
K890121 · KGI
Lunar
Radiology · 454d
Cleared Apr 10, 1990
ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANT
K895267 · DZE
Artech Corp.
Dental · 230d
Cleared Apr 10, 1990
ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS
K895433 · DSP
Aries Medical, Inc.
Cardiovascular · 215d
Cleared Apr 10, 1990
HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.
K895524 · JXG
Theramed, Inc.
Neurology · 210d