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
155089–155112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 31, 1983
CAPNOGRAPH
K831776 · CCK
Datascope Corp.
Anesthesiology · 151d
Cleared Oct 31, 1983
PATIENT MONITOR #RM-100
K831817 · DRT
Honeywell, Inc.
Cardiovascular · 147d
Cleared Oct 31, 1983
CENTRAL STATION MONITOR CSM-100
K831818 · DRT
Honeywell, Inc.
Cardiovascular · 147d
Cleared Oct 31, 1983
ROUND-BEEHIVE- DISSECTORS 3/8
K831912 · GDI
Ormed Mfg., Inc.
General & Plastic Surgery · 139d
Cleared Oct 31, 1983
STRUNG NEURO SPONGE PATTIES-X-RAY-
K831914 · GDY
Ormed Mfg., Inc.
General & Plastic Surgery · 139d
Cleared Oct 31, 1983
MEDICAL ELECTRONICS-PRINTER CLOCK
K832012 · DSF
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
LME PATIENT MONITOR SMS 151
K832013 · DPS
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
MULTISCRIPTOR EK #403 VARIOUS MODEL
K832014 · DPS
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
MULTISCRIPTOR EK VARIOUS #43
K832015 · DPS
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
LME BLOOD PRESSURE MONITOR
K832017 · DSK
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
SERVOMED COMPACT MONITOR 181/10105002
K832018 · DRT
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
SCD SKIN TEMP. SENSORS #3400 ETC
K832090 · FLL
Science Development Corp.
General Hospital · 125d
Cleared Oct 31, 1983
MULTISCRIPTOR EK 36/101 047 02,05
K832130 · DPS
Litton Medical Electronics
Cardiovascular · 122d
Cleared Oct 31, 1983
SIMPLISCRIPTOR EK 31/101 037 16
K832184 · DPS
Litton Medical Electronics
Cardiovascular · 117d
Cleared Oct 31, 1983
GOAT ANTI-HUMAN IMMUNOGLOBULINS-
K832256 · DFH
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC
K832258 · DEW
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
GOAT ANTI-HUMAN KAPPA AFFINITY
K832260 · DEO
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS
K832262 · CZN
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN IGA A CHAIN
K832263 · CZP
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN IGM H CHAIN
K832265 · DFT
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN KAPPA AFFINITY
K832266 · DFH
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN LAMBA
K832267 · DES
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
GOAT ANTI-HUMAN LAMBA
K832270 · DEH
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
ISOLATION BAG 3M
K832318 · KGY
3M Company
General & Plastic Surgery · 108d