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
127393–127416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 1990
SILICONE PLUG
K896678 · HRX
Orthopedic Systems, Inc.
Orthopedic · 64d
Cleared Jan 30, 1990
VITRO T4-EIA-XT
K896865 · KLI
In Vitro Diagnostics, Inc.
Chemistry · 55d
Cleared Jan 30, 1990
MODIFIED ASSESS(R) PEAK FLOW METER
K896953 · BZH
Health Products, Inc.
Anesthesiology · 56d
Cleared Jan 30, 1990
NOVELTY GRADUATION SUNGLASSES
K900046 · HQY
Gibson Greetings, Inc.
Ophthalmic · 27d
Cleared Jan 30, 1990
KESTREL LENS CASE 731H-893S/P-1700-2611
K900053 · LRX
Kestrel
Ophthalmic · 27d
Cleared Jan 30, 1990
KESTREL LENS CASE 1543-893S/P-1700-2611
K900054 · LRX
Kestrel
Ophthalmic · 27d
Cleared Jan 29, 1990
8400ST VOLUME VENTILATOR
K894322 · CBK
Bird Products Corp.
Anesthesiology · 199d
Cleared Jan 29, 1990
GENESIS III, (MOD. 7003/7004)
K894370 · DXK
Biosound, Inc.
Cardiovascular · 199d
Cleared Jan 29, 1990
PASCO MIC/ID GRAM-POSITIVE PANEL
K895215 · JWY
Difco Laboratories, Inc.
Microbiology · 164d
Cleared Jan 29, 1990
CLEARVIEW CHLAMYDIA
K895280 · LJC
Unipath , Ltd.
Microbiology · 158d
Cleared Jan 29, 1990
ACME COATED ORTHODONTIC ARCHWIRE
K895483 · EJF
Acme-Monaco Corp.
Dental · 140d
Cleared Jan 29, 1990
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466
K895631 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 132d
Cleared Jan 29, 1990
CONNECTION SHIELDS CODES 5C4213 AND 5C4215
K895673 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 131d
Cleared Jan 29, 1990
MODIFIED ELISA FOR CHLAMYDIA
K896032 · LJC
Fairleigh Dickinson Laboratories, Inc.
Chemistry · 105d
Cleared Jan 29, 1990
MODIFIED QUINTON SINGLE LUMEN CATHETER
K896252 · MPB
Quinton, Inc.
Gastroenterology & Urology · 91d
Cleared Jan 29, 1990
INPOUCH-TV POUCH
K896296 · JSN
Biomed Diagnostics, Inc.
Microbiology · 90d
Cleared Jan 29, 1990
QUANTUM HIP STEM
K896325 · JDI
Depuy, Inc.
Orthopedic · 88d
Cleared Jan 29, 1990
PORGES CYTOLOGY BRUSHES
K896425 · FDX
Porges Corp.
Gastroenterology & Urology · 82d
Cleared Jan 29, 1990
PORGES DIATHERMY SNARE
K896507 · KNS
Porges Corp.
Gastroenterology & Urology · 75d
Cleared Jan 29, 1990
MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-III
K896541 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 75d
Cleared Jan 29, 1990
EASI-LAV ADULT GASTRIC LAVAGE KIT
K896573 · KDH
Clairson Industries, LLC
Gastroenterology & Urology · 70d
Cleared Jan 29, 1990
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K896965 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 45d
Cleared Jan 29, 1990
REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)
K900017 · JPK
Helena Laboratories
Hematology · 27d
Cleared Jan 26, 1990
SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283
K882955 · DXN
Kontron Instruments, Inc.
Cardiovascular · 561d