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
170665–170688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1978
OPTI 110/12/50 HSG
K781540 · ITY
Siemens Corp.
Radiology · 6d
Cleared Sep 11, 1978
OXYGEN SUPPLY TUBE, DISP., PLASTIC
K781231 · BYX
Rtec
Anesthesiology · 52d
Cleared Sep 11, 1978
DENTAL X-RAY UNIT
K781286 · EHD
Siemens Corp.
Radiology · 47d
Cleared Sep 11, 1978
DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH
K781287 · EAG
Siemens Corp.
Radiology · 47d
Cleared Sep 11, 1978
DENTAL X-RAY UNIT HELIODENT 70
K781288 · EHD
Siemens Corp.
Radiology · 47d
Cleared Sep 11, 1978
TUBING, FLEXIBLE, MEDICAL GAS
K781416 · BYX
Vitalab Products Corp.
Anesthesiology · 27d
Cleared Sep 11, 1978
CAP-MOBILE
K781425 · IZL
Philips Medical Systems (Cleveland),...
Radiology · 20d
Cleared Sep 11, 1978
FLEXTUBES:9, 20, 26
K781428 · BYX
Bourns Medical Systems, Inc.
Anesthesiology · 21d
Cleared Sep 11, 1978
BUCKY WALL STAND
K781473 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 14d
Cleared Sep 11, 1978
SERIES 7000 GAS MACHINE
K781492 · BSZ
Narco Mckesson Co.
Anesthesiology · 14d
Cleared Sep 11, 1978
HEARING AID, UNITRON MODEL 761P
K781502 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 07, 1978
LUMBAR NERVE ROOT SHIELD
K780706
Heyer Schulte Corp.
Neurology · 135d
Cleared Sep 07, 1978
CYTOLOGY BRUSH
K780872 · BTG
CooperVision, Inc.
Pathology · 100d
Cleared Sep 07, 1978
FLUORESCENT ANTI-NATIVE DNA TEST
K780899 · DHN
Kallestad Laboratories, Inc.
Immunology · 97d
Cleared Sep 07, 1978
AUTOREFRACTOR, SUBJECTIVE
K781014 · HKO
Cavitron Corp.
Ophthalmic · 83d
Cleared Sep 07, 1978
DINAMAP MODEL 846
K781053 · DSK
Applied Medical Research
Cardiovascular · 77d
Cleared Sep 07, 1978
DINAMAP MODEL 848
K781064 · DSK
Applied Medical Research
Cardiovascular · 73d
Cleared Sep 07, 1978
GENERATOR, CARDIAC PULSE, 250B
K781090 · DXY
Telectronics, Inc.
Cardiovascular · 66d
Cleared Sep 07, 1978
CUTTER RESIFLEX FOLEY CATHETERS
K781140 · DJC
Cutler Laboratories, Inc.
Toxicology · 17d
Cleared Sep 07, 1978
PATIENT AID, MODEL DM-351
K781176 · FKQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 57d
Cleared Sep 07, 1978
PULSE GENERATOR MODEL 208
K781178 · DXY
Elema-Schonander, Inc.
Cardiovascular · 59d
Cleared Sep 07, 1978
PENLIGHTS
K781228 · KYT
Abco Dealers, Inc.
General Hospital · 52d
Cleared Sep 07, 1978
GAVAGE ADMIN. SET
K781230 · KNT
Mcgaw Laboratories
Gastroenterology & Urology · 51d
Cleared Sep 07, 1978
MODEL 80100A, PATIENT DATA MEMORY
K781360 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 31d