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
137281–137304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 16, 1987
INFUSION PUMP MODEL 275
K872516 · FRN
Avi, Inc.
General Hospital · 175d
Cleared Dec 16, 1987
PROTECT DROPS/SAME AS K874070
K874194 · EJK
John O. Butler
Dental · 63d
Cleared Dec 15, 1987
ANGIOSCOPE
K865017 · DQX
Mansfield Scientific, Inc.
Cardiovascular · 357d
Cleared Dec 15, 1987
FITNESS RECUMBENT ERGOMETER, MODEL FT1400
K872548 · DPS
Invacare Corp.
Cardiovascular · 169d
Cleared Dec 15, 1987
SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO
K873195 · DYB
Angiomedics, Inc.
Cardiovascular · 123d
Cleared Dec 15, 1987
MONOPOLAR CAUTERY BLADE TIP #TM-1701
K873653 · JOS
Arthropedics, Inc.
General & Plastic Surgery · 96d
Cleared Dec 15, 1987
MONOPOLAR CAUTERY CONICAL TIP #TM-1702
K873654 · JOS
Arthropedics, Inc.
General & Plastic Surgery · 96d
Cleared Dec 15, 1987
MONOPOLAR CAUTERY RETROGADE TIP #TM-1703
K873655 · JOS
Arthropedics, Inc.
General & Plastic Surgery · 96d
Cleared Dec 15, 1987
ANTI-SHOCK TROUSERS
K873997 · JOW
Simulaids, Inc.
Cardiovascular · 75d
Cleared Dec 15, 1987
300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER
K874090 · DRO
Medac, Inc.
Cardiovascular · 69d
Cleared Dec 15, 1987
STRATUM D
K874697 · LDD
Alternative Design Systems, Inc.
Cardiovascular · 26d
Cleared Dec 14, 1987
SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL
K872254 · HHR
Surgical Laser Technologies, Inc.
Obstetrics & Gynecology · 208d
Cleared Dec 14, 1987
DIFFERENTIAL I.M. SCREENING TEST
K873297 · KTN
Sclavo, Inc.
Immunology · 118d
Cleared Dec 14, 1987
PARAMAX CALCIUM REAGENT
K873519 · CIC
Baxter Healthcare Corp
Chemistry · 104d
Cleared Dec 14, 1987
PARAMAX MAGNESIUM REAGENT
K873530 · JGJ
Baxter Healthcare Corp
Chemistry · 104d
Cleared Dec 14, 1987
MEDATRON CUVETTE DISC
K873656 · JRI
Medatron, Inc.
Chemistry · 95d
Cleared Dec 14, 1987
PARAMAX ISE CHLORIDE CALIBRATOR
K873743 · JIT
Baxter Healthcare Corp
Chemistry · 89d
Cleared Dec 14, 1987
GUAZE SPONGES
K874067 · EFQ
Interpro Intl., Inc.
General & Plastic Surgery · 70d
Cleared Dec 14, 1987
REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE
K874099 · KGO
Biopro, Inc.
General Hospital · 67d
Cleared Dec 14, 1987
MULTI-FUNCTION BLOOD GAS CONTROL
K874408 · JJS
Bionostics, Inc.
Chemistry · 47d
Cleared Dec 14, 1987
MODEL V4 AUDIOMETER
K874516 · EWO
Digital Hearing Systems Corp.
Ear, Nose, Throat · 42d
Cleared Dec 14, 1987
HI-TOUCH (TM) BRAND SURGICAL GLOVES
K874539 · KGO
Apex Medical Technologies, Inc.
General Hospital · 41d
Cleared Dec 14, 1987
I.M.N. LATEX
K874678 · KTN
Biokit USA, Inc.
Immunology · 31d
Cleared Dec 14, 1987
E600B FOOTSWITCH
K874794 · BWA
Valleylab, Inc.
General & Plastic Surgery · 21d