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
137761–137784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 1987
TONOMETER TAPES
K873917 · HKX
Richmond Products, Inc.
Ophthalmic · 38d
Cleared Nov 02, 1987
MODIFIED RETINAL CAMERA MODEL CR4-45NM
K874017 · HKI
Canon USA, Inc.
Ophthalmic · 31d
Cleared Nov 02, 1987
SURGICAL PREP RAZOR, STRAIGHT TYPE
K874234 · LWK
Derma-Safe Co.
General & Plastic Surgery · 18d
Cleared Oct 30, 1987
TOXOPLASMA GONDII
K864981 · GMN
Virion (U.S.), Inc.
Microbiology · 312d
Cleared Oct 30, 1987
PLAN-32 SOFTWARE
K871810 · JAD
Oncology Systems, Inc.
Radiology · 175d
Cleared Oct 30, 1987
THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT
K872090 · DQT
Ideas For Medicine, Inc.
Cardiovascular · 151d
Cleared Oct 30, 1987
IMPRA DUAL LUMEN SUBCLAVIAN CATHETER
K872163 · DQY
Impra, Inc.
Cardiovascular · 147d
Cleared Oct 30, 1987
POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE
K872182 · DQY
Polystan C/O Vitalcor, Inc.
Cardiovascular · 144d
Cleared Oct 30, 1987
KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET
K873048 · LMB
Eastman Kodak Company
Radiology · 87d
Cleared Oct 30, 1987
ADAC MODEL ARC-5000, GAMMA CAMERA
K873075 · JWM
Adac Laboratories
Radiology · 85d
Cleared Oct 30, 1987
SPECTRAMED RESPIRATORY GAS ANALYZER
K873194 · CBS
Draeger Medical, Inc.
Anesthesiology · 78d
Cleared Oct 30, 1987
DISPOSABLE CONDENSATE BOTTLE FOR 7200 VENTILATOR
K873447 · BYH
Dhd Medical Products Div. Diemolding...
Anesthesiology · 74d
Cleared Oct 30, 1987
BLOOD ANALYSIS GAS
K873587 · BXK
National Welders
Anesthesiology · 56d
Cleared Oct 30, 1987
PORTABLE VENTILATOR PATIENT CIRCUIT
K873900 · BZO
Puritan Bennett Corp.
Anesthesiology · 36d
Cleared Oct 30, 1987
ULTIMETER
K873956 · LHO
Radiation Measurements, Inc.
Radiology · 32d
Cleared Oct 30, 1987
GX-MOBILE X-RAY UNIT
K873982 · IZL
Gendex Corp.
Radiology · 30d
Cleared Oct 29, 1987
COX RAPID HEAT TRANSFER STERILIZER
K872643 · KMH
Cox Sterile Products, Inc.
General Hospital · 115d
Cleared Oct 29, 1987
QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2
K873011 · LAS
Quantimetrix Medical Industries
Chemistry · 86d
Cleared Oct 29, 1987
EASY-TEST SALICYLATE (SAL) #16691
K873425 · DKJ
Em Diagnostic Systems, Inc.
Chemistry · 65d
Cleared Oct 29, 1987
EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645
K873426 · KLP
Em Diagnostic Systems, Inc.
Toxicology · 65d
Cleared Oct 29, 1987
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95
K873436 · DLJ
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Oct 29, 1987
OPHTHALAS DYE OPHTHALMIC LASER
K873460 · HQF
Biophysic Medical, Inc.
Ophthalmic · 62d
Cleared Oct 29, 1987
TODD MEDICAL/SKILLED CARE PRODUCTS
K873469 · LRP
Todd Medical, Inc.
General & Plastic Surgery · 62d
Cleared Oct 29, 1987
AFFINITY TOTAL THYROXINE IMMUNIT
K873518 · KLI
Bd Becton Dickinson Vacutainer...
Chemistry · 58d