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
130969–130992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1989
WOODLYN OPHTHALMIC PROJECTOR
K890992 · HOS
Woodlyn, Inc.
Ophthalmic · 79d
Cleared May 17, 1989
FETAL HEMOGLOBIN
K892241 · GHQ
Sure-Tech Diagnostic Associates, Inc.
Hematology · 56d
Cleared May 17, 1989
NOVA GEL(TM) JO-1
K892897 · LLL
Inova Diagnostics, Inc.
Immunology · 27d
Cleared May 17, 1989
SITE PERISTALTIC CASSETTE
K892911 · HQC
Site Microsurgical Systems, Inc.
Ophthalmic · 27d
Cleared May 16, 1989
DRI-VENT ARTERIAL BLOOD SAMPLING KIT
K883840 · LKB
Concord Laboratories, Inc.
General Hospital · 246d
Cleared May 16, 1989
MODEL G7731D WASHER/DISINFECTOR FOR DENTAL INSTRU.
K884151 · LDS
Miele Appliances, Inc.
General Hospital · 225d
Cleared May 16, 1989
PH BLOOD GAS CONTROL PRODUCTS
K884266 · JPK
Alko Diagnostic Corp.
Chemistry · 217d
Cleared May 16, 1989
KITCHIN DENTAL ABCESS DRAIN
K885231 · EIE
Kitchin, Inc.
Dental · 147d
Cleared May 16, 1989
ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER
K890055 · IYN
Acuson Corp.
Radiology · 130d
Cleared May 16, 1989
THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION
K890407 · HIS
Circle Rubber Corp.
Obstetrics & Gynecology · 112d
Cleared May 16, 1989
GENTLE EXPRESSIONS ELECTRIC BREAST PUMP
K890588 · HGX
Healthteam
Obstetrics & Gynecology · 99d
Cleared May 16, 1989
GRIESHABER VISCOELASTIC INJECTION SYSTEM
K890783 · FRN
Grieshaber & Co.
General Hospital · 90d
Cleared May 16, 1989
TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K890919 · LZU
Eagle Vision, Inc.
Ophthalmic · 82d
Cleared May 16, 1989
TRANSESOPHAGEAL TRANSDUCER PEF-511SA
K890969 · IYO
Toshiba Medical Systems
Radiology · 78d
Cleared May 16, 1989
INTRAVASCULAR ADMINISTRATION SET MODEL 60040
K891009 · FPK
3M Company
General Hospital · 77d
Cleared May 16, 1989
5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER
K891309 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 67d
Cleared May 16, 1989
CVIS ULTRA-SCAN ONE IMAGING SYSTEM
K891386 · IYO
Cardiovascular Imaging Systems, Inc.
Radiology · 68d
Cleared May 16, 1989
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
K891482 · KWL
Depuy, Inc.
Orthopedic · 60d
Cleared May 16, 1989
GDS ENZYMATIC THEOPHYLLINE REAGENT
K891761 · LCY
Gds Diagnostics
Chemistry · 53d
Cleared May 16, 1989
TDX BARBITURATES SERUM
K892650 · DIS
Abbott Laboratories
Chemistry · 34d
Cleared May 16, 1989
ACA VANCOMYCIN CALIBRATOR
K892901 · DLJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared May 15, 1989
HARBORIN CENTRAL VENOUS CATHETER
K884628 · DQR
Harbor Medical Devices, Inc.
Cardiovascular · 189d
Cleared May 15, 1989
A-V(TM) SOFTOUCH UHF CARDIAC PIGTAIL
K885348 · DQO
Mallinckroot, Inc.
Cardiovascular · 138d
Cleared May 15, 1989
VZV MICROASSAY
K890642 · LFY
Diamedix Corp.
Microbiology · 96d