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
98233–98256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 1996
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
K955794 · CZP
Randox Laboratories, Ltd.
Immunology · 105d
Cleared Apr 05, 1996
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
K955797 · DFT
Randox Laboratories, Ltd.
Immunology · 105d
Cleared Apr 05, 1996
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR
K955798 · DEW
Randox Laboratories, Ltd.
Immunology · 105d
Cleared Apr 05, 1996
SMITH S-100 TIME & TEMPERATURE CONTROL
K955825 · EGY
Smith Companies Dental Products
Radiology · 101d
Cleared Apr 05, 1996
TEMNO ACHIEVE BIOPSY NEEDLE
K960064 · KNW
Bauer Medical, Inc.
Gastroenterology & Urology · 91d
Cleared Apr 05, 1996
TEMNO DOUBLE SHOT BIOPSY NEEDLE
K960065 · KNW
Bauer Medical, Inc.
Gastroenterology & Urology · 91d
Cleared Apr 05, 1996
ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE
K960476 · GEI
Ethicon, Inc.
General & Plastic Surgery · 64d
Cleared Apr 05, 1996
MODIFIED HAND INSTRUMENT DEVICES
K960748 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 42d
Cleared Apr 05, 1996
MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC
K960804 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 37d
Cleared Apr 05, 1996
LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND...
K960866 · KNY
Lake Region Mfg., Inc.
Gastroenterology & Urology · 32d
Cleared Apr 05, 1996
ACTIVE LH IRMA
K961109 · CEP
Diagnostic Systems Laboratories, Inc.
Chemistry · 16d
Cleared Apr 05, 1996
TROGARD TROCAR DIALATING TROCAR SYSTEM
K961175 · GCJ
Conmedcorp
General & Plastic Surgery · 11d
Cleared Apr 05, 1996
CEFEPIME, 30 MCG, SENSI-DISC
K961188 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 10d
Cleared Apr 04, 1996
CARDIO PERFECT ST 2001
K935732 · DSI
Cardio Control BV
Cardiovascular · 855d
Cleared Apr 04, 1996
CARDIOSOFT/CARDIOSYS
K951130 · LOS
Marquette Electronics, Inc.
Cardiovascular · 388d
Cleared Apr 04, 1996
MIDMARK MIDLINE CATHETER
K951620 · FOZ
Menlo Care, Inc.
General Hospital · 363d
Cleared Apr 04, 1996
TEMPERATURE PROBE-TP150
K952800 · FMT
Contour Medical Technology, Inc.
General Hospital · 290d
Cleared Apr 04, 1996
TEMPERATURE PROBE-TP250
K952801 · FMT
Contour Medical Technology, Inc.
General Hospital · 290d
Cleared Apr 04, 1996
TEMPERATURE PROBE-TP350
K952803 · FMT
Contour Medical Technology, Inc.
General Hospital · 290d
Cleared Apr 04, 1996
TEMPERATURE PROBE-TP450
K952804 · FMT
Contour Medical Technology, Inc.
General Hospital · 290d
Cleared Apr 04, 1996
TEMPERATURE PROBE-TP550
K952805 · FMT
Contour Medical Technology, Inc.
General Hospital · 290d
Cleared Apr 04, 1996
TEMPERATURE PROBE-TP650
K952807 · FMT
Contour Medical Technology, Inc.
General Hospital · 290d
Cleared Apr 04, 1996
GIP/MEID-GLOBE HOT BIOPSY FORCEPS
K953355 · KGE
Medi-Globe Corp.
Gastroenterology & Urology · 262d
Cleared Apr 04, 1996
OSTEONICS OFFSET HIP STEMS
K954598 · JDI
Osteonics Corp.
Orthopedic · 184d