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
105385–105408 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1994
HP BACK POINTER SYSTEM
K943802 · IWE
Medtec, Inc.
Radiology · 125d
Cleared Dec 07, 1994
OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE
K943987 · GWM
Innerspace Medical, Inc.
Neurology · 113d
Cleared Dec 07, 1994
COMFIT
K944140 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 104d
Cleared Dec 07, 1994
TOPOGRAPHIC MODELING SYSTEM 2 TMS-2
K944207 · HLQ
Computed Anatomy, Inc.
Ophthalmic · 100d
Cleared Dec 07, 1994
ACCUCON
K944223 · HQD
Innovision, Inc.
Ophthalmic · 99d
Cleared Dec 07, 1994
NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES
K944355 · FMF
Nissho Corp.
General Hospital · 91d
Cleared Dec 07, 1994
CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS
K944604 · DKZ
Beckman-Diagnostic Systems Group
Toxicology · 79d
Cleared Dec 07, 1994
CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM
K944605 · LCM
Beckman-Diagnostic Systems Group
Toxicology · 79d
Cleared Dec 07, 1994
MULTIPLE
K945282 · HQY
Mi MI Progress Co. , Ltd.
Ophthalmic · 40d
Cleared Dec 07, 1994
PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416
K945322 · CEO
Emd Chemicals, Inc.
Chemistry · 36d
Cleared Dec 07, 1994
PHENYTOIN CALIBRATORS
K945337 · DLJ
Diagnostic Reagents, Inc.
Toxicology · 36d
Cleared Dec 07, 1994
MULTIPLE
K945341 · HQY
Mi MI Progress Co. , Ltd.
Ophthalmic · 36d
Cleared Dec 07, 1994
R-MED MOTORIZED LAPAROSCOPIC HANDLE
K945637 · GCJ
R-Med, Inc.
General & Plastic Surgery · 21d
Cleared Dec 07, 1994
DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER
K945657 · BYD
Tec II Medical, Inc.
Anesthesiology · 20d
Cleared Dec 07, 1994
CATCO NEONATAL PALATE GUARD
K945727 · BRW
Catco Medical, Inc.
Anesthesiology · 15d
Cleared Dec 07, 1994
ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER)
K945745 · BTR
Wolfe Tory Medical, Inc.
Anesthesiology · 14d
Cleared Dec 06, 1994
METRICIDE
K930284 · MED
Metrex Research Corp.
General Hospital · 686d
Cleared Dec 06, 1994
METRICIDE 28
K931052 · MED
Metrex Research Corp.
General Hospital · 658d
Cleared Dec 06, 1994
PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI
K931466 · JWH
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 622d
Cleared Dec 06, 1994
METRICIDE PLUS 30 LIQUID CHEMICAL GERMICIDE
K931592 · MED
Metrex Research Corp.
General Hospital · 615d
Cleared Dec 06, 1994
SES100
K940065 · ISD
Southwest Ergonomics
Physical Medicine · 334d
Cleared Dec 06, 1994
CAREPAK
K942350 · CAF
Precision Medical, Inc.
Anesthesiology · 203d
Cleared Dec 06, 1994
KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS
K943154 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 159d
Cleared Dec 06, 1994
ABBOTT LTE INFUSION PUMP
K944125 · FRN
Abbott Laboratories
General Hospital · 105d