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
138361–138384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1987
OSCAR(TM) PB255 OXIMETER CAPNOMETER
K872760 · CCK
Datex Division Instrumentarium Corp.
Anesthesiology · 63d
Cleared Sep 14, 1987
HISTOMATIC SLIDE STAINER, CODE-ON VERSION
K872916 · KPA
Fisher Scientific Co., LLC
Hematology · 52d
Cleared Sep 14, 1987
HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE
K873033 · JHI
Serono Diagnostics, Inc.
Immunology · 41d
Cleared Sep 14, 1987
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
K873052 · CEP
American Dade
Chemistry · 41d
Cleared Sep 14, 1987
MICRO-READER II
K873138 · JJQ
Hyperion, Inc.
Chemistry · 35d
Cleared Sep 14, 1987
MODEL SI AND SP BEHIND-THE-EAR HEARING AID
K873376 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 21d
Cleared Sep 14, 1987
DAHLBERG MODEL MH BEHIND-THE-EAR HEARING AID
K873397 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 21d
Cleared Sep 14, 1987
EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690
K873424 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 20d
Cleared Sep 14, 1987
S3086 ARTERIAL, S3087 VENOUS NEONATAL HEMODIALYSIS
K873455 · FJK
Dravon Medical, Inc.
Gastroenterology & Urology · 17d
Cleared Sep 11, 1987
CHLAMYSET ANTIBODY EIA
K864457 · LJC
Orion Corp.
Microbiology · 303d
Cleared Sep 11, 1987
U. V. GERMICIDAL UNIT
K871615 · KMH
Lorvic Corp.
General Hospital · 137d
Cleared Sep 11, 1987
DENTURE CLEANSING TABLET
K871785 · EFT
Pennex Products Co., Inc.
Dental · 128d
Cleared Sep 11, 1987
BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052
K872073 · JIT
American Monitor Corp.
Chemistry · 105d
Cleared Sep 11, 1987
DENTOCULT-SM CULTURE-PADDLE
K872301 · JSI
Orion Corp.
Microbiology · 88d
Cleared Sep 11, 1987
MISTMASTER
K872315 · CCQ
Sonora Respiratory Products, Inc.
Anesthesiology · 86d
Cleared Sep 11, 1987
SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL
K872444 · EBF
3M Company
Dental · 80d
Cleared Sep 11, 1987
TITANE SL DENTAL BURR
K872471 · ECM
Titane SL Co.
Dental · 80d
Cleared Sep 11, 1987
ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR
K872589 · GEX
Class, Inc.
General & Plastic Surgery · 72d
Cleared Sep 11, 1987
ROS-TR SYSTEM
K873143 · DZE
Ross Systems C/O...
Dental · 32d
Cleared Sep 11, 1987
CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
K873304 · LJX
Miles Laboratories, Inc.
Hematology · 24d
Cleared Sep 11, 1987
'MICROLYTE 4/5'
K873345 · JFP
Kone Instruments, Inc.
Chemistry · 23d
Cleared Sep 11, 1987
GEMENI URIC ACID U.V.
K873358 · CDO
Electro-Nucleonics Laboratories, Inc.
Chemistry · 21d
Cleared Sep 11, 1987
ALLEN MALLEABLE ANESTHESIA SCREEN
K873370 · FWZ
Edgewater Medical Equipment Systems
General & Plastic Surgery · 21d
Cleared Sep 11, 1987
MODIFIED ROUND (BEEHIVE) DISSECTOR 3/8
K873391 · GDY
Ormed Mfg., Inc.
General & Plastic Surgery · 18d