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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
106129–106152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 1994
MEDICAL DEVICE TECHNOLOGIES MANUAL BIOPSY NEEDLE
K944837 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 13, 1994
QUANTASE PHENYLALANINE ASSAY
K922547 · JNB
Porton Cambridge , Ltd.
Chemistry · 864d
Cleared Oct 13, 1994
PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM
K931423 · LWJ
Orthomed
Orthopedic · 570d
Cleared Oct 13, 1994
APHLELISA KIT
K933588 · MID
Louisville Apl Diagnostics, Inc.
Immunology · 444d
Cleared Oct 13, 1994
GALILEO ENDOSCOPES
K934649 · FBO
Galileo Electro-Optics Corp.
Gastroenterology & Urology · 379d
Cleared Oct 13, 1994
GLASSMAN SILICONE CATHETER
K934895 · EZL
Axiom Medical, Inc.
Gastroenterology & Urology · 373d
Cleared Oct 13, 1994
HAND-HELD NEBULIZER
K940257 · CAF
Nutec, Inc.
Anesthesiology · 267d
Cleared Oct 13, 1994
AGGRO/LINK VW COFACTOR SOFTWARE
K940792 · JOZ
Chrono-Log Corp.
Hematology · 233d
Cleared Oct 13, 1994
PATIENT SUPPORT SYSTEM
K940872 · FNG
Arylift, Inc.
General Hospital · 230d
Cleared Oct 13, 1994
BURDICK PRO2 OXIMETER
K941351 · DQA
Burdick Corp.
Anesthesiology · 205d
Cleared Oct 13, 1994
OCU-FLEX-38 (POLYMACON)
K941998 · LPL
Ocu-Ease Optical Products, Inc.
Ophthalmic · 171d
Cleared Oct 13, 1994
INJECT-SNARE
K942110 · FDI
Endovations
Gastroenterology & Urology · 164d
Cleared Oct 13, 1994
POWDERED DISPOSABLE LATEX EXAM GLOVES/ANNEXURES
K942149 · LYY
Ti-Mate Prophylactic Devices , Ltd.
General Hospital · 163d
Cleared Oct 13, 1994
SHIMAZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF/GR
K942731 · IZO
Shimadzu Corp.
Radiology · 147d
Cleared Oct 13, 1994
3301 PULSE OXIMETER
K943404 · DQA
Bci Intl., Inc.
Anesthesiology · 91d
Cleared Oct 13, 1994
UNIHEART
K943600 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 80d
Cleared Oct 13, 1994
PHACO NEEDLES AND TIPS
K943672 · HQC
Microsurgical Technology, Inc.
Ophthalmic · 79d
Cleared Oct 13, 1994
SCIMED 8 FRENCH BIG-MAX GUIDE CATHETER
K943777 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 72d
Cleared Oct 13, 1994
7 FRENCH LARGE LUMEN TRIGUIDE-PLUS
K943783 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 71d
Cleared Oct 13, 1994
COMFIT (STERILE)
K944141 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 49d
Cleared Oct 13, 1994
LSVP INTERNATIONAL BIOPSY FORCEPS
K944770 · FCL
Lsvp Intl., Inc.
Gastroenterology & Urology · 16d
Cleared Oct 13, 1994
CATCO UROLOGICAL CATHETER
K944782 · EZD
Catco Medical, Inc.
Gastroenterology & Urology · 16d
Cleared Oct 12, 1994
PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM
K944077 · ESD
Argosy Electronics
Ear, Nose, Throat · 51d
Cleared Oct 11, 1994
CKS POROUS COATED FEMORAL COMPONENT
K933935 · HRY
Techmedica, Inc.
Orthopedic · 426d