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
154321–154344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 17, 1984
LOEFFLER MEDIUM TUBE
K834426 · JSG
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
THIOGEL MEDIUM TUBE
K834427 · JSG
Otisville Biotech, Inc.
Microbiology · 33d
Cleared Jan 17, 1984
HYDROPULSE(GROSSAN)
K834507 · IRP
Amrex-Zetron, Inc.
Physical Medicine · 27d
Cleared Jan 17, 1984
JAY CUSHION
K834517 · KIC
Jay Medical, Ltd.
Physical Medicine · 27d
Cleared Jan 17, 1984
VENTI-VOICE NASAL CATHETER
K834522 · ESE
Respiratory Support Products, Inc.
Ear, Nose, Throat · 27d
Cleared Jan 17, 1984
ENDOBRONCHIAL TWIN LUMEN TUBE
K834565 · BTS
Portex, Inc.
Anesthesiology · 20d
Cleared Jan 17, 1984
SWIVEL ADAPTOR W/ALARM PORT
K840015 · BZA
Portex, Inc.
Anesthesiology · 13d
Cleared Jan 13, 1984
3-DAY RELEASE OF ETHYLENE OXIDE DEVICE
K832352 · BSO
Parke-Davis Co.
Anesthesiology · 182d
Cleared Jan 13, 1984
OMNI-FAL I & II
K833009 · JJY
American Monitor Corp.
Chemistry · 129d
Cleared Jan 13, 1984
DOCTOR VELLETTE'S INJECTOR
K833426 · EJI
Deproco, Inc.
Dental · 101d
Cleared Jan 13, 1984
HDL EX-SEP PRECIPITATING REAGENT
K833431 · LBR
Preventive Diagnostics Corp.
Chemistry · 100d
Cleared Jan 13, 1984
X-RAY SHIELD
K833558 · EHB
Moyco Industries, Inc.
Radiology · 92d
Cleared Jan 13, 1984
ORTHO ELT-8/DS HEMATOLOGY ANALYZER
K833618 · GKZ
Ortho Diagnostic Systems, Inc.
Hematology · 91d
Cleared Jan 13, 1984
UR/RITE SYSTEM
K833666 · JQW
Wright Laboratories, Inc.
Chemistry · 87d
Cleared Jan 13, 1984
ALBUMIN REAGENT CS-716
K833699 · CIX
Fisher Scientific Co., LLC
Chemistry · 87d
Cleared Jan 13, 1984
ACA THYROXINE ANALYTICAL TEST PACK
K833701 · LBH
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 87d
Cleared Jan 13, 1984
NA/K FLUIDA PACK FOR NOVA 1 ANALYZER
K833712 · JGS
Fisher Scientific Co., LLC
Chemistry · 84d
Cleared Jan 13, 1984
ALKALINE PHOSPHATASE-RATE
K833744 · CJE
Seragen Diagnostics, Inc.
Chemistry · 79d
Cleared Jan 13, 1984
TECH. RA-1000 SYS SERUM CHLORIDE
K833746 · CHJ
Technicon Instruments Corp.
Chemistry · 79d
Cleared Jan 13, 1984
THERAPEUTIC DRUG CONTROL
K833761 · DKB
Icl Scientific
Toxicology · 79d
Cleared Jan 13, 1984
SHABAN 9865 IL#78637 JUNCTION BLOC
K833804 · JJF
Shaban Mfg. Co.
Chemistry · 73d
Cleared Jan 13, 1984
ARGYLE JET TRACHEAL TUBE
K833807 · BTR
Sherwood Medical Co.
Anesthesiology · 73d
Cleared Jan 13, 1984
INTERAD 520
K833821 · IYX
Interad Systems, Inc.
Radiology · 72d
Cleared Jan 13, 1984
FSH RIA
K833852 · CGJ
Syncor Intl. Corp.
Chemistry · 70d